The following data is part of a premarket notification filed by American Diagnostica, Inc. with the FDA for Acticlot Protein S, Model 843l.
| Device ID | K012386 |
| 510k Number | K012386 |
| Device Name: | ACTICLOT PROTEIN S, MODEL 843L |
| 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 | 2001-07-27 |
| Decision Date | 2001-09-14 |
| Summary: | summary |