510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883683Substantially Equivalent

Hemoglobin

Tech-Co, Inc., Oak Park MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883683 is the FDA 510(k) clearance record for HEMOGLOBIN, a class II device, cleared for Tech-Co, Inc. on under FDA product code GJZ (Cyanomethemoglobin Reagent And Standard Solution). FDA records list 19 510(k) clearances for Tech-Co, Inc., from to . As of , FDA records show no recalls naming K883683.

Clearance record

Decision date
Received
(38 days to decision)
Product code
GJZ Cyanomethemoglobin Reagent And Standard Solution
Regulation
21 CFR 864.7500
Device class
Class II
Review panel
Hematology
Applicant
Tech-Co, Inc. 24111 Beverly, Oak Park MI
Third party review
No

Clearances, product code GJZ

Trailing 12 months

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

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