The following data is part of a premarket notification filed by Rochdiag with the FDA for Tina-quant Alpha-1 Antitrypsin.
| Device ID | K010978 |
| 510k Number | K010978 |
| Device Name: | TINA-QUANT ALPHA-1 ANTITRYPSIN |
| Classification | Alpha-1-antitrypsin, Antigen, Antiserum, Control |
| Applicant | ROCHDIAG 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor ROCHDIAG 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | DEM |
| CFR Regulation Number | 866.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-13 |
| Decision Date | 2001-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336130230 | K010978 | 000 |
| 04015630927562 | K010978 | 000 |