510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K954048Substantially Equivalent

Variant Hemoglobinopathy Program

Bio-Rad, Hercules CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954048 is the FDA 510(k) clearance record for VARIANT HEMOGLOBINOPATHY PROGRAM, a class II device, cleared for Bio-Rad on under FDA product code GKA (Abnormal Hemoglobin Quantitation). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K954048.

Clearance record

Decision date
Received
(84 days to decision)
Product code
GKA Abnormal Hemoglobin Quantitation
Regulation
21 CFR 864.7415
Device class
Class II
Review panel
Hematology
Applicant
Bio-Rad 4000 Alfred Nobel Dr., Hercules CA
510(k) summary
Summary
Third party review
No

Clearances, product code GKA

Trailing 12 months

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

FDA records show no clearances under product code GKA in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GKA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260