CKC — Vanillin Pyruvate, Alt/Sgpt Class I

FDA Device Classification

FDA product code CKC covers "Vanillin Pyruvate, Alt/Sgpt", a Class I medical device regulated under 21 CFR 862.1030. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
CKC
Device Class
Class I
Regulation Number
862.1030
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K832791miles laboratoriesSERAYZER ALT/SGPT REAGENT STRIPSOctober 14, 1983
K780507gamma enterprisesSERUM GLUTAMIC-PYRUVIC TRANSAMINASEMay 3, 1978