The following data is part of a premarket notification filed by American Diagnostica, Inc. with the FDA for Spectrolyse Pai-1, Model 101201.
| Device ID | K063323 |
| 510k Number | K063323 |
| Device Name: | SPECTROLYSE PAI-1, MODEL 101201 |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | AMERICAN DIAGNOSTICA, INC. 500 WEST AVENUE Stamford, CT 06902 |
| Contact | David Teicher |
| Correspondent | David Teicher AMERICAN DIAGNOSTICA, INC. 500 WEST AVENUE Stamford, CT 06902 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-03 |
| Decision Date | 2007-08-15 |
| Summary: | summary |