510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895984Substantially Equivalent

Wako(tm) Autokit Gamma-Gt

FUJIFILM Healthcare Americas Corporation, Richmond VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895984 is the FDA 510(k) clearance record for WAKO(TM) AUTOKIT GAMMA-GT, a class I device, cleared for Wako Chemicals USA, Inc. on under FDA product code JPZ (Colorimetric Method, Gamma-Glutamyl Transpeptidase). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K895984.

Clearance record

Decision date
Received
(26 days to decision)
Product code
JPZ Colorimetric Method, Gamma-Glutamyl Transpeptidase
Regulation
21 CFR 862.1360
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Wako Chemicals USA, Inc. 1600 Bellwood Rd., Richmond VA
Third party review
No

Clearances, product code JPZ

Trailing 12 months

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

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