510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933078Substantially Equivalent

Beckman Alpha-1-Microglobulin (A1m) Reagent

Beckman Instruments, Inc., Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933078 is the FDA 510(k) clearance record for BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT, a class I device, cleared for Beckman Instruments, Inc. on under FDA product code MGA (Alpha-1 Microglobulin, Antigen, Antiserum, Control). FDA records list 281 510(k) clearances for Beckman Instruments, Inc., from to . As of , FDA records show no recalls naming K933078.

Clearance record

Decision date
Received
(202 days to decision)
Product code
MGA Alpha-1 Microglobulin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5400
Device class
Class I
Review panel
Immunology
Applicant
Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337, Brea CA
510(k) summary
Summary
Third party review
No

Clearances, product code MGA

Trailing 12 months

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

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