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

2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase

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

CER is the FDA product code for 2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase, a class II device type, regulated under 21 CFR 862.1440. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
CER
Device name
2,4-Dinitrophenylhydrazine, 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
1
Ingested recalls
0

Clearances, product code CER

By decision year
1 clearance under product code CER with a decision year between 1979 and 1979, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CER by decision year
YearClearances
19791

Applicants with the most clearances

Product code CER
Applicants holding the most 510(k) clearances under product code CER
ApplicantClearances
Volu Sol Medical Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code