This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | GAMMA DAB (125I) AFP RIA KIT |
| Generic Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Applicant | INCSTAR CORP. |
| Date Received | 1986-06-10 |
| Decision Date | 1986-08-22 |
| PMA | P790032 |
| Supplement | S001 |
| Product Code | LOK |
| Advisory Committee | Immunology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INCSTAR CORP. 1990 Insustrial Blvd. p.o. Box 285 stillwater, MN 55082-0285 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P790032 | Original Filing | |
| S003 | 1991-02-26 | Normal 180 Day Track |
| S002 | 1990-12-24 | Normal 180 Day Track |
| S001 | 1986-06-10 | Special (immediate Track) |