510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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CGCClass I

Radioimmunoassay, Gastrin

21 CFR 862.1325 / Clinical Chemistry
FDA source (opens on fda.gov)

CGC is the FDA product code for Radioimmunoassay, Gastrin, a class I device type, regulated under 21 CFR 862.1325. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
CGC
Device name
Radioimmunoassay, Gastrin
Regulation
21 CFR 862.1325
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
10
Ingested recalls
2

Clearances, product code CGC

By decision year
10 clearances under product code CGC with a decision year between 1978 and 1996, 1981 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code CGC by decision year
YearClearances
19781
19813
19821
19831
19843
19961

Applicants with the most clearances

Product code CGC
Applicants holding the most 510(k) clearances under product code CGC
ApplicantClearances
Immuno Nuclear Corp.2
Abbott Medical1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Biosyn, Ltd.1
Clinical Assays, Inc.1
Siemens Healthcare Diagnostics Inc.1
Inter Science Institute1
Syncor Intl. Corp.1
United Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code