510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063306Substantially Equivalent

Ace Hemoglobin A1c Reagent, Model Aci-21, Hemoglobin A1c Calibrators, Model S2-72, Hemoglobin A1c Controls, Model C2-72

Alfa Wassermann, West Caldwell NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063306 is the FDA 510(k) clearance record for ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72, a class II device, cleared for Alfa Wassermann, Inc. on under FDA product code LCP (Assay, Glycosylated Hemoglobin). FDA records list 9 510(k) clearances for Alfa Wassermann, Inc., from to . As of , FDA records show no recalls naming K063306.

Clearance record

Decision date
Received
(167 days to decision)
Product code
LCP Assay, Glycosylated Hemoglobin
Regulation
21 CFR 864.7470
Device class
Class II
Review panel
Hematology
Applicant
Alfa Wassermann, Inc. 4 Henderson Dr., West Caldwell NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LCP

Trailing 12 months

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

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