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

Vanillin Pyruvate, Alt/Sgpt

21 CFR 862.1030 / Clinical Chemistry
FDA source (opens on fda.gov)

CKC is the FDA product code for Vanillin Pyruvate, Alt/Sgpt, a class I device type, regulated under 21 CFR 862.1030. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CKC
Device name
Vanillin Pyruvate, Alt/Sgpt
Regulation
21 CFR 862.1030
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
2
Ingested recalls
0

Clearances, product code CKC

By decision year
2 clearances under product code CKC with a decision year between 1978 and 1983, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CKC by decision year
YearClearances
19781
19831

Applicants with the most clearances

Product code CKC
Applicants holding the most 510(k) clearances under product code CKC
ApplicantClearances
Gamma Enterprises, Inc.1
Miles Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code CKC.