510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080911Substantially Equivalent

Variant Nbs Sickle Cell Program Reagent Kit, Variant Nbs Newborn Screening System and Variant Nbs Workstation with

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)

K080911 is the FDA 510(k) clearance record for VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH, a class II device, cleared for Bio-Rad Laboratories Inc., Clinical Systems Divisi on under FDA product code GKA (Abnormal Hemoglobin Quantitation). FDA records list 3 510(k) clearances for Bio-Rad Laboratories Inc., Clinical Systems Divisi, from to . As of , FDA records show no recalls naming K080911.

Clearance record

Decision date
Received
(30 days to decision)
Product code
GKA Abnormal Hemoglobin Quantitation
Regulation
21 CFR 864.7415
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 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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GKA, 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