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

Radioimmunoassay, Human Growth Hormone

21 CFR 862.1370 / Clinical Chemistry
FDA source (opens on fda.gov)

CFL is the FDA product code for Radioimmunoassay, Human Growth Hormone, a class I device type, regulated under 21 CFR 862.1370. As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
CFL
Device name
Radioimmunoassay, Human Growth Hormone
Regulation
21 CFR 862.1370
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
36
Ingested recalls
5

Clearances, product code CFL

By decision year
36 clearances under product code CFL with a decision year between 1978 and 1997, 1995 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code CFL by decision year
YearClearances
19781
19811
19821
19831
19842
19853
19861
19882
19891
19902
19912
19921
19931
19942
19957
19965
19973

Applicants with the most clearances

Product code CFL
Applicants holding the most 510(k) clearances under product code CFL
ApplicantClearances
Diagnostic Systems Laboratories, Inc.10
Nichols Institute Diagnostics4
Siemens Healthcare Diagnostics Inc.2
Immuno Nuclear Corp.2
Medix Biotech, Inc.2
Nichols Institute2
Bioclone Australia Pty, Ltd.1
Boots-Celltech Diagnostics, Inc.1
Calbiochem-Behring Corp.1
Corning Nichols Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order