# A-Kem, Inc.

- Location (FDA's records): Clifton, NJ
- FDA decisions: 13 (1987–1988): 13 510(k) clearances
- Product codes: JFL (1), CIX (1), CGX (1), JGS (1), CIG (1), LFP (1), JIX (1), CEK (1), CGA (1), CJA (1), JJE (1), JFS (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K884224: Total Bilirubin Reagent Kit for Astra Systems (Dec 15, 1988)
- K884227: Calibrator Standard Kit for Astra System (Dec 9, 1988)
- K884225: Total Protein Reagent Kit for Astra Systems (Dec 9, 1988)
- K884226: Amylase Reagent Kit for Astra Systems (Dec 9, 1988)
- K882587: A-Kem Albumin Reagent Kit for Astra System (Aug 8, 1988)
- K882586: A-Kem Calcium Reagent Kit for Astra System (Aug 8, 1988)
- K873129: Carbon Dioxide Reagent Kit (Oct 23, 1987)
- K873131: Creatinine Reagent Kit (Oct 23, 1987)

Source page: https://510kreport.com/company/a-kem