510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821106Substantially Equivalent

Triglyzyme V Eiken

Syn-Kit, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821106 is the FDA 510(k) clearance record for TRIGLYZYME V EIKEN, a class I device, cleared for Syn-Kit, Inc. on under FDA product code JGY (Colorimetric Method, Triglycerides). FDA records list 34 510(k) clearances for Syn-Kit, Inc., from to . As of , FDA records show no recalls naming K821106.

Clearance record

Decision date
Received
(15 days to decision)
Product code
JGY Colorimetric Method, Triglycerides
Regulation
21 CFR 862.1705
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Syn-Kit, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JGY

Trailing 12 months

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

FDA records show no clearances under product code JGY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JGY, 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