Home › Device types › JIN
Nitroprusside, Ketones (Urinary, Non-Quant.)
FDA product code JIN · Class 1 · Clinical Chemistry
277
Registered devices
187
Adverse events
14
Recalls
24
510(k) clearances
Devices with this code
KetoBM — KETOBM USA LLCAccutest — JANT PHARMACAL CORPORATIONFORA — FORA CARE INC.FORA — FORA CARE INC.FORA — FORA CARE INC.TECO DIAGNOSTICS — TECO DIAGNOSTICSRapid Response — BTNX IncTECO DIAGNOSTICS — TECO DIAGNOSTICSTECO DIAGNOSTICS — TECO DIAGNOSTICSMoore Medical — MOORE MEDICAL LLCYodoc 10 — DFI CO.,LTDTECO DIAGNOSTICS — TECO DIAGNOSTICSSureMediks B-Ketone Test Strips (25pcs/box) — Rasimo Systems LLCUrine Reagent Strips, 10-parameter — LW SCIENTIFIC, INC.URINE REAGENT STRIPS — Urit Medical Electronic Co., Ltd.Urine Reagent Strips — Urit Medical Electronic Co., Ltd.KetoBM — Ketobm LLCβ-Hydroxybutyrate 21 FS — DiaSys Diagnostic Systems GmbHB-Hydroxybutyrate LiquiColor® — STANBIO LABORATORY, L.P.Care Touch — FUTURE DIAGNOSTICS LLCCARDINAL HEALTH — Cardinal Health 200, LLCbkt ß-Ketone Test Strips (50 pcs/box) — Adam LawrenceAUTION™ MAX AX-4022 Analyzer — ARKRAY USA, INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-02 | DFI Co., Ltd. | The devices were distributed without required FDA premarket clearance or approval. |
| 2025-11-22 | Changchun Wancheng Bio-Electron Co., Ltd. | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; |
| 2023-10-02 | Stanbio Laboratory, LP | Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The r |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2022-03-08 | MEDLINE INDUSTRIES, LP - Northfield | Product was improperly store which may cause a delay in results. |
| 2021-07-12 | Stanbio Laboratory, LP | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
| 2021-07-12 | Stanbio Laboratory, LP | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
| 2021-07-12 | Stanbio Laboratory, LP | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
| 2021-07-12 | Stanbio Laboratory, LP | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
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