FDA product code MGA: Alpha-1 Microglobulin, Antigen, Antiserum, Control
MGA is the FDA product code for alpha-1 microglobulin, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5400 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under MGA. The average 510(k) review took 164 days (median 164). FDA has posted 1 recall for MGA devices.
Classification
| Field | Value |
|---|---|
| Device name | Alpha-1 Microglobulin, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5400 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MGA clearance
Top MGA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Instruments, Inc. | 2 | 1997-04-21 |
Most recent MGA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K965033 | Beckman Instruments, Inc. | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT | 1997-04-21 | 125 |
| K933078 | Beckman Instruments, Inc. | BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT | 1994-01-11 | 202 |
Recalls for MGA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-09-17.
Frequently asked questions
What is FDA product code MGA?
MGA is the FDA product code for alpha-1 microglobulin, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5400 and reviewed by the Immunology panel.
What device class is MGA?
Class I, regulation 21 CFR 866.5400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MGA?
Across 2 cleared submissions the average was 164 days from receipt to decision (median 164).
Which companies have the most MGA clearances?
Beckman Instruments, Inc. (2).
Have MGA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-09-17.
Next steps
- Run an FDA pathway report with predicate devices for product code MGA
- Run a recall and safety report across every MGA manufacturer
- Watch product code MGA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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