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

Alpha-1 Microglobulin, Antigen, Antiserum, Control

21 CFR 866.5400 / Immunology
FDA source (opens on fda.gov)

MGA is the FDA product code for Alpha-1 Microglobulin, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5400. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MGA
Device name
Alpha-1 Microglobulin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5400
Device class
Class I
Review panel
Immunology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code MGA

By decision year
2 clearances under product code MGA with a decision year between 1994 and 1997, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MGA by decision year
YearClearances
19941
19971

Applicants with the most clearances

Product code MGA
Applicants holding the most 510(k) clearances under product code MGA
ApplicantClearances
Beckman Instruments, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code