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

Radioimmunoassay, Estrone

21 CFR 862.1280 / Clinical Chemistry
FDA source (opens on fda.gov)

CGF is the FDA product code for Radioimmunoassay, Estrone, a class I device type, regulated under 21 CFR 862.1280. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
CGF
Device name
Radioimmunoassay, Estrone
Regulation
21 CFR 862.1280
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
4
Ingested recalls
4

Clearances, product code CGF

By decision year
4 clearances under product code CGF with a decision year between 1984 and 1997, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CGF by decision year
YearClearances
19841
19871
19941
19971

Applicants with the most clearances

Product code CGF
Applicants holding the most 510(k) clearances under product code CGF
ApplicantClearances
Diagnostic Systems Laboratories, Inc.2
Corning Medical & Scientific1
Diagnostics Biochem Canada, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order