510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K063643Substantially Equivalent

Modification to Variant II: Hemoglobin A1c Program, Beta-Thalassemia Short Program and Total Ghb Program

Bio-Rad Laboratories Inc., Clinical Systems Divisi, Hercules CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063643 is the FDA 510(k) clearance record for MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM, a class II device, cleared for Bio-Rad Laboratories Inc., Clinical Systems Divisi on under FDA product code LCP (Assay, Glycosylated Hemoglobin). FDA records list 3 510(k) clearances for Bio-Rad Laboratories Inc., Clinical Systems Divisi, from to . As of , FDA records show one recall naming K063643.

Clearance record

Decision date
Received
(20 days to decision)
Product code
LCP Assay, Glycosylated Hemoglobin
Regulation
21 CFR 864.7470
Device class
Class II
Review panel
Hematology
Applicant
Bio-Rad Laboratories Inc., Clinical Systems Divisi 4000 Alfred Nobel Dr., Hercules CA
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