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

Chromatographic Separation, Lactate Dehydrogenase Isoenzymes

21 CFR 862.1445 / Clinical Chemistry
FDA source (opens on fda.gov)

CEX is the FDA product code for Chromatographic Separation, Lactate Dehydrogenase Isoenzymes, a class II device type, regulated under 21 CFR 862.1445. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CEX
Device name
Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Regulation
21 CFR 862.1445
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
8
Ingested recalls
0

Clearances, product code CEX

By decision year
8 clearances under product code CEX with a decision year between 1977 and 1987, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code CEX by decision year
YearClearances
19771
19781
19801
19822
19841
19851
19871

Applicants with the most clearances

Product code CEX
Applicants holding the most 510(k) clearances under product code CEX
ApplicantClearances
Berwick Medical Products, Inc.1
Bio-Reagents & Diagnostics, Inc.1
Data Medical Associates, Inc.1
Harleco Diagnostics1
Helena Laboratories, Corp.1
Seragen Diagnostics, Inc.1
Union Carbide Corp.1
Worthington Biochemical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code