510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801771Substantially Equivalent

Alpha-Thal Screen 20 Test Kit & 100 Kit

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

K801771 is the FDA 510(k) clearance record for ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT, a class II device, cleared for Isolab, Inc. on under FDA product code LGL (Assay, Bart'S, Hemoglobin). FDA records list 44 510(k) clearances for Isolab, Inc., from to . As of , FDA records show no recalls naming K801771.

Clearance record

Decision date
Received
(172 days to decision)
Product code
LGL Assay, Bart'S, Hemoglobin
Regulation
21 CFR 864.7500
Device class
Class II
Review panel
Hematology
Applicant
Isolab, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LGL

Trailing 12 months

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

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