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

Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase

21 CFR 862.1440 / Clinical Chemistry
FDA source (opens on fda.gov)

CFH is the FDA product code for Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase, a class II device type, regulated under 21 CFR 862.1440. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CFH
Device name
Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
Regulation
21 CFR 862.1440
Device class
Class II
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
13
Ingested recalls
0

Clearances, product code CFH

By decision year
13 clearances under product code CFH with a decision year between 1976 and 2005, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code CFH by decision year
YearClearances
19761
19771
19791
19811
19821
19841
19851
19861
19881
19892
20021
20051

Applicants with the most clearances

Product code CFH
Applicants holding the most 510(k) clearances under product code CFH
ApplicantClearances
Hycel, Inc.2
Anco Medical Reagents & Assoc.1
Arkray, Inc.1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Biorent Diagnostic, Inc.1
Careside, Inc.1
Helena Laboratories, Corp.1
Kulzer GmbH1
Sterling Diagnostics, Inc.1
Tech-Co, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code