510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050613Substantially Equivalent

Quantia Beta-2 Microglobulin

Biokit, S.A., Barcelona, ES / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050613 is the FDA 510(k) clearance record for QUANTIA BETA-2 MICROGLOBULIN, a class II device, cleared for Biokit, S.A. on under FDA product code JZG (System, Test, Beta-2-Microglobulin Immunological). FDA records list 23 510(k) clearances for Biokit, S.A., from to . As of , FDA records show no recalls naming K050613.

Clearance record

Decision date
Received
(159 days to decision)
Product code
JZG System, Test, Beta-2-Microglobulin Immunological
Regulation
21 CFR 866.5630
Device class
Class II
Review panel
Immunology
Applicant
Biokit, S.A. Llissa D'Amunt, Barcelona, ES
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JZG

Trailing 12 months

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

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