510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K950172Substantially Equivalent

Wako Autokit Glucose

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

K950172 is the FDA 510(k) clearance record for WAKO AUTOKIT GLUCOSE, a class II device, cleared for Wako Chemicals USA, Inc. on under FDA product code CGA (Glucose Oxidase, Glucose). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K950172.

Clearance record

Decision date
Received
(261 days to decision)
Product code
CGA Glucose Oxidase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Wako Chemicals USA, Inc. 1600 Bellwood Rd., Richmond VA
510(k) summary
Statement
Third party review
No

Clearances, product code CGA

Trailing 12 months
1 clearance under product code CGA in the twelve months to November 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CGA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260