Atlas FDA

MGA

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Alpha-1 Microglobulin, Antigen, Antiserum, Control
Device class
Class I (low risk)
Regulation
21 CFR 866.5400
Medical specialty
Immunology
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RecordFirmDate
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT (K965033)Beckman Instruments, Inc.1997-04-21
BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT (K933078)Beckman Instruments, Inc.1994-01-11

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Every clearance here is in the API, with alerts when new ones post.