Atlas FDA

JID

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Photometric Method, Ammonia
Device class
Class I (low risk)
Regulation
21 CFR 862.1065
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2015: 40 · 2016: 10 · 2019: 13 · 2020: 26 · 2021: 19 · 2023: 26
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDateBuilder
CARESIDE AMMONIA (K991371)Careside, Inc.1999-08-03+ Add
KODAK EKTACHEM CLINICAL CHEM. NH3 (K820723)Eastman Kodak Company1982-04-01+ Add
AMMONIA TEST (K813366)Wako Pure Chemical Industries, Ltd.1981-12-22+ Add

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