510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860812Substantially Equivalent

Sickle Cell Reagent Set

MichClone Associates, Inc., Detroit MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860812 is the FDA 510(k) clearance record for SICKLE CELL REAGENT SET, a class II device, cleared for Michclone Associates, Inc. on under FDA product code GHM (Test, Sickle Cell). FDA records list 3 510(k) clearances for Michclone Associates, Inc., from to . As of , FDA records show 3 recalls naming K860812.

Clearance record

Decision date
Received
(38 days to decision)
Product code
GHM Test, Sickle Cell
Regulation
21 CFR 864.7825
Device class
Class II
Review panel
Hematology
Applicant
Michclone Associates, Inc. 15003 W 8 Mile, Detroit MI
Third party review
No

Clearances, product code GHM

Trailing 12 months

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

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