510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K885227Substantially Equivalent

Clinistat Hemoglobin Reagent Test

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

K885227 is the FDA 510(k) clearance record for CLINISTAT HEMOGLOBIN REAGENT TEST, a class II device, cleared for Heraeus Kulzer, Inc. on under FDA product code KHG (Whole Blood Hemoglobin Determination). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K885227.

Clearance record

Decision date
Received
(66 days to decision)
Product code
KHG Whole Blood Hemoglobin Determination
Regulation
21 CFR 864.7500
Device class
Class II
Review panel
Hematology
Applicant
Heraeus Kulzer, Inc. Diagnostics Division, Elkhart IN
Third party review
No

Clearances, product code KHG

Trailing 12 months

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

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