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

Radioimmunoassay, Immunoreactive Insulin

21 CFR 862.1405 / Clinical Chemistry
FDA source (opens on fda.gov)

CFP is the FDA product code for Radioimmunoassay, Immunoreactive Insulin, a class I device type, regulated under 21 CFR 862.1405. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
CFP
Device name
Radioimmunoassay, Immunoreactive Insulin
Regulation
21 CFR 862.1405
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
27
Ingested recalls
8

Clearances, product code CFP

By decision year
27 clearances under product code CFP with a decision year between 1977 and 1996, 1978 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code CFP by decision year
YearClearances
19772
19784
19793
19814
19823
19831
19841
19851
19891
19903
19922
19951
19961

Applicants with the most clearances

Product code CFP
Applicants holding the most 510(k) clearances under product code CFP
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic2
Micromedic Systems2
Ventrex Laboratories, Inc.2
Abbott Medical1
American Laboratory Products Company1
Bio-Rad Laboratories Inc.1
Boehringer Mannheim Corp.1
Cambridge Medical Technology1
Clinical Assays, Inc.1
Corning Medical & Scientific1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order