510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912028Substantially Equivalent

Uric Acid (Uricase) Reagent, Universal

Enzyme Technology, Inc., Shelton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912028 is the FDA 510(k) clearance record for URIC ACID (URICASE) REAGENT, UNIVERSAL, a class I device, cleared for Enzyme Technology, Inc. on under FDA product code KNK (Acid, Uric, Uricase (Colorimetric)). FDA records list 5 510(k) clearances for Enzyme Technology, Inc., from to . As of , FDA records show no recalls naming K912028.

Clearance record

Decision date
Received
(224 days to decision)
Product code
KNK Acid, Uric, Uricase (Colorimetric)
Regulation
21 CFR 862.1775
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Enzyme Technology, Inc. 415 Howe Ave., Shelton CT
510(k) summary
Statement
Third party review
No

Clearances, product code KNK

Trailing 12 months

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

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