510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K892801Substantially Equivalent

Clinistat Total Bilirubin Reagent Test

Kulzer GmbH, Elkhart IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892801 is the FDA 510(k) clearance record for CLINISTAT TOTAL BILIRUBIN REAGENT TEST, a class II device, cleared for Heraeus Kulzer, Inc. on under FDA product code CIG (Diazo Colorimetry, Bilirubin). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K892801.

Clearance record

Decision date
Received
(120 days to decision)
Product code
CIG Diazo Colorimetry, Bilirubin
Regulation
21 CFR 862.1110
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Heraeus Kulzer, Inc. Diagnostics Division, Elkhart IN
Third party review
No

Clearances, product code CIG

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