510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820630Substantially Equivalent

Quik-Sep Hemoglobin F Assay & Control

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

K820630 is the FDA 510(k) clearance record for QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL, a class II device, cleared for Isolab, Inc. on under FDA product code JPC (Hemoglobin F Quantitation). FDA records list 44 510(k) clearances for Isolab, Inc., from to . As of , FDA records show no recalls naming K820630.

Clearance record

Decision date
Received
(109 days to decision)
Product code
JPC Hemoglobin F Quantitation
Regulation
21 CFR 864.7455
Device class
Class II
Review panel
Hematology
Applicant
Isolab, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JPC

Trailing 12 months

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

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