The following data is part of a premarket notification filed by American Diagnostica, Inc. with the FDA for Imubind Tpa Elisa, Model 860.
| Device ID | K013492 |
| 510k Number | K013492 |
| Device Name: | IMUBIND TPA ELISA, MODEL 860 |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | AMERICAN DIAGNOSTICA, INC. 222 RAILROAD AVE. Greenwich, CT 06830 |
| Contact | John B Berryman |
| Correspondent | John B Berryman AMERICAN DIAGNOSTICA, INC. 222 RAILROAD AVE. Greenwich, CT 06830 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-22 |
| Decision Date | 2002-03-13 |
| Summary: | summary |