Atlas FDA

CGC

10 FDA 510(k) clearances · Product code

57 daysmedian time to decision
115 days90th percentile
10clearances measured

FDA profile

Official device name
Radioimmunoassay, Gastrin
Device class
Class I (low risk)
Regulation
21 CFR 862.1325
Medical specialty
Clinical Chemistry
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RecordFirmDate
GASTRIN EIA MODEL 06B-555017 (K961276)Biosyn , Ltd.1996-05-30
GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY (K842079)Immuno Nuclear Corp.1984-06-26
GASTRIN RIA (K841963)Syncor Intl. Corp.1984-06-25
DPC GASTRIN KIT (K833489)Diagnostic Products Corp.1984-01-30
BLOOD GAS & FLAME PHOTOMETER INSTRU- (K831075)United Diagnostics, Inc.1983-06-22
GASTRIN RADIOIMMUNOASSAY KIT (125-I) (K821175)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-05-14
GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT (K812727)Immuno Nuclear Corp.1981-11-05
GASTRIN RIA DIAGNOSTIC KIT (K812004)Abbott Laboratories1981-07-28
GASTRIN RADIOIMMUNOASSAY TEST (K810722)Clinical Assays, Inc.1981-05-27
GASTRIN RIA MODULE (K771953)Inter Science Institute1978-01-20

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