Atlas FDA

CJO

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1050
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI (K122323)Siemens Healthcare Diagnostics2012-08-28
DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR (K121907)Siemens Healthcare Diagnostics2012-07-23
BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K982328)Bayer Corp.1999-01-29
ALKALINE PHOSPHATASE ISOYZME REAGENT SET (K770155)Gelman Instrument Co.1977-01-31

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Every clearance here is in the API, with alerts when new ones post.