Atlas FDA

CIQ

7 FDA 510(k) clearances · Product code

50 daysmedian time to decision
81 days90th percentile
7clearances measured

FDA profile

Official device name
Diazo, Ast/Sgot
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1100
Medical specialty
Clinical Chemistry
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RecordFirmDate
ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) (K881173)Tech-Co, Inc.1988-06-07
SGOT (AST) REAGENT SET (K860216)Sterling Diagnostics, Inc.1986-04-03
GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET (K855189)Technostics Intl.1986-01-14
SGOT REAGENT SET (K844322)Livonia Diagnostics, Inc.1984-11-27
SGOT REAGENT SET (K841065)Medical Specialties, Inc.1984-05-01
SGOT REAGENT SET (K821209)Omega Medical Electronics1982-07-14
SGOT REAGENT SET (K820466)Anco Medical Reagents & Assoc.1982-03-11

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