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FDA product code GKJ · Class 1 · Hematology

6
Registered devices
105
Adverse events
1
Recalls
6
510(k) clearances

Devices with this code

Hemaprep — J P Gilbert Company IncCELL-DYN — ABBOTT LABORATORIESHemaPrep — Cellavision ABHemaPrep — Cellavision ABUniCel DxH — Beckman Coulter, Inc.LH Slidemaker — Beckman Coulter, Inc.

Recent recalls

DateFirmReason
2005-12-15Beckman Coulter IncThere is a risk of sample misidentification when processing samples in the Manual aspiration mode.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.