Home › Device types › JIA
Enzymatic Methods, Galactose
FDA product code JIA · Class 1 · Clinical Chemistry
15
Registered devices
0
Adverse events
6
Recalls
9
510(k) clearances
Devices with this code
SPOTCHECK — ASTORIA-PACIFIC, INC.Accuwell — ASTORIA-PACIFIC, INC.GSP Neonatal Total Galactose Kit — Wallac OyGalactose (with Membrane Plate) ELISA — DRG International IncGalactose (without Membrane Plate) ELISA — DRG International IncGalactose (without Membrane Plate) ELISA — DRG International IncMP Biomedicals LLC — Mp Biomedicals, LLCMP Biomedicals LLC — Mp Biomedicals, LLCNeonatal Total Galactose kit — Wallac OyGalactose (with Membrane Plate) ELISA — DRG International IncGSP Neonatal Total Galactose kit — Wallac OySPOTCHECK — ASTORIA-PACIFIC, INC.MP Biomedicals LLC — Mp Biomedicals, LLCMP Biomedicals LLC — Mp Biomedicals, LLCSPOTCHECK — ASTORIA-PACIFIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2004-09-08 | PerkinElmer LAS Inc | There is an increase in the number of normal specimen results below the lowest calibrator and based on a report that the normal controls were running low, somet |
| 2004-01-09 | Perkin Elmer Life and Analytical Sciences Inc | The device is not stable throughout its labeled expiration date. |
| 2004-01-09 | Perkin Elmer Life and Analytical Sciences Inc | The device is not stable throughout its labeled expiration date. |
| 2003-05-30 | PerkinElmer Life Sciences Inc | The device is not stable throughout its labeled expiration date. |
| 2003-05-30 | PerkinElmer Life Sciences Inc | The device is not stable throughout its labeled expiration date. |
| 2003-05-30 | PerkinElmer Life Sciences Inc | The device is not stable throughout its labeled expiration date. |
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