510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K831391Substantially Equivalent

Shot Gun Kit for Ck-Mb

Serapine Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831391 is the FDA 510(k) clearance record for SHOT GUN KIT FOR CK-MB, a class II device, cleared for Serapine Corp. on under FDA product code JHT (Chromatographic Separation, Cpk Isoenzymes). FDA records list one 510(k) clearance for Serapine Corp. As of , FDA records show no recalls naming K831391.

Clearance record

Decision date
Received
(189 days to decision)
Product code
JHT Chromatographic Separation, Cpk Isoenzymes
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Serapine Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JHT

Trailing 12 months

FDA records hold no clearances under product code JHT in the trailing twelve months.

FDA records show no clearances under product code JHT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JHT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260