The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for The Theratest Aca Test.
| Device ID | K905301 |
| 510k Number | K905301 |
| Device Name: | THE THERATEST ACA TEST |
| Classification | Activated Partial Thromboplastin |
| Applicant | THERATEST LABORATORIES, INC. 2201 WEST CAMPBELL PARK DR. Chicago, IL 60612 -3501 |
| Contact | Marius Teodorescu |
| Correspondent | Marius Teodorescu THERATEST LABORATORIES, INC. 2201 WEST CAMPBELL PARK DR. Chicago, IL 60612 -3501 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-27 |
| Decision Date | 1991-01-14 |