510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842152Substantially Equivalent

Sickling Hemoglobin Controls, Normal

Isolab, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842152 is the FDA 510(k) clearance record for SICKLING HEMOGLOBIN CONTROLS, NORMAL, a class II device, cleared for Isolab, Inc. on under FDA product code GHM (Test, Sickle Cell). FDA records list 44 510(k) clearances for Isolab, Inc., from to . As of , FDA records show no recalls naming K842152.

Clearance record

Decision date
Received
(102 days to decision)
Product code
GHM Test, Sickle Cell
Regulation
21 CFR 864.7825
Device class
Class II
Review panel
Hematology
Applicant
Isolab, Inc. 4221 Richmond Rd., NW, Walker 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