510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894951Substantially Equivalent

Modified Hemoglobin Reagent Set

Macomb Biotechnology, Inc., Romeo MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894951 is the FDA 510(k) clearance record for MODIFIED HEMOGLOBIN REAGENT SET, a class II device, cleared for Macomb Biotechnology, Inc. on under FDA product code GKK (Cyanomethemoglobin). FDA records list 2 510(k) clearances for Macomb Biotechnology, Inc., from to . As of , FDA records show no recalls naming K894951.

Clearance record

Decision date
Received
(96 days to decision)
Product code
GKK Cyanomethemoglobin
Regulation
21 CFR 864.7500
Device class
Class II
Review panel
Hematology
Applicant
Macomb Biotechnology, Inc. 70001 Powell Rd., P.O. Box 466, Romeo MI
Third party review
No

Clearances, product code GKK

Trailing 12 months

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

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