The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Tina-quant Alpha Particle-1-antitrypsin Assay.
| Device ID | K972640 |
| 510k Number | K972640 |
| Device Name: | TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY |
| Classification | Alpha-1-antitrypsin, Antigen, Antiserum, Control |
| Applicant | BOEHRINGER MANNHEIM CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Mary Koning |
| Correspondent | Mary Koning BOEHRINGER MANNHEIM CORP. 2380A BISSO LN. Concord, CA 94520 |
| Product Code | DEM |
| CFR Regulation Number | 866.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-15 |
| Decision Date | 1998-01-09 |
| Summary: | summary |