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

Radioimmunoassay, Estriol

21 CFR 862.1265 / Clinical Chemistry
FDA source (opens on fda.gov)

CGI is the FDA product code for Radioimmunoassay, Estriol, a class I device type, regulated under 21 CFR 862.1265. As of , FDA records hold 42 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
CGI
Device name
Radioimmunoassay, Estriol
Regulation
21 CFR 862.1265
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
42
Ingested recalls
2

Clearances, product code CGI

By decision year
42 clearances under product code CGI with a decision year between 1977 and 1998, 1982 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code CGI by decision year
YearClearances
19772
19784
19795
19805
19815
19826
19831
19843
19853
19861
19901
19921
19942
19962
19981

Applicants with the most clearances

Product code CGI
Applicants holding the most 510(k) clearances under product code CGI
ApplicantClearances
Amersham Corp.4
Bio-Rad4
Siemens Healthcare Diagnostics Inc.3
Diagnostic Systems Laboratories, Inc.3
BD Becton Dickinson Vacutainer Systems Preanalytic2
Cambridge Nuclear Corp.2
IMMUNOTECH s.r.o.2
Micromedic Systems2
New England Nuclear2
Abbott Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order