510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771101Substantially Equivalent

Hemoglobin Analyzer & Perform. Check Set

The Dow Chemical Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771101 is the FDA 510(k) clearance record for HEMOGLOBIN ANALYZER & PERFORM. CHECK SET, a class II device, cleared for The Dow Chemical Co. on under FDA product code GIG (Hemoglobinometer). FDA records list 26 510(k) clearances for The Dow Chemical Co., from to . As of , FDA records show no recalls naming K771101.

Clearance record

Decision date
Received
(31 days to decision)
Product code
GIG Hemoglobinometer
Regulation
21 CFR 864.7500
Device class
Class II
Review panel
Hematology
Applicant
The Dow Chemical Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GIG

Trailing 12 months

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

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