510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810309Substantially Equivalent

Rubella Antibodies Test Reagents

Calbiochem-Behring Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810309 is the FDA 510(k) clearance record for RUBELLA ANTIBODIES TEST REAGENTS, a class II device, cleared for Calbiochem-Behring Corp. on under FDA product code GOL (Antigen, Ha (Including Ha Control), Rubella). FDA records list 41 510(k) clearances for Calbiochem-Behring Corp., from to . As of , FDA records show no recalls naming K810309.

Clearance record

Decision date
Received
(34 days to decision)
Product code
GOL Antigen, Ha (Including Ha Control), Rubella
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Applicant
Calbiochem-Behring Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GOL

Trailing 12 months

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

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