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

Radioimmunoassay, Cortisol

21 CFR 862.1205 / Clinical Chemistry
FDA source (opens on fda.gov)

CGR is the FDA product code for Radioimmunoassay, Cortisol, a class II device type, regulated under 21 CFR 862.1205. As of , FDA records hold 84 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
CGR
Device name
Radioimmunoassay, Cortisol
Regulation
21 CFR 862.1205
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
84
Ingested recalls
7

Clearances, product code CGR

By decision year
84 clearances under product code CGR with a decision year between 1976 and 2025, 1980 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code CGR by decision year
YearClearances
19762
19772
19782
19798
19809
19814
19826
19834
19849
19853
19862
19872
19881
19894
19902
19912
19922
19932
19942
19952
19971
19981
19991
20021
20041
20052
20062
20213
20231
20251

Applicants with the most clearances

Product code CGR
Applicants holding the most 510(k) clearances under product code CGR
ApplicantClearances
Siemens Healthcare Diagnostics Inc.8
Corning Medical & Scientific3
Diagnostic Systems Laboratories, Inc.3
Nichols Institute Diagnostics3
Nuclear Medical Laboratories, Inc.3
Amersham Corp.2
BD Becton Dickinson Vacutainer Systems Preanalytic2
Bio-Rad Laboratories Inc.2
Biotecx Laboratories, Inc.2
Cambridge Medical Technology2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order