The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Ultra-1 Thromboplastin.
| Device ID | K913249 |
| 510k Number | K913249 |
| Device Name: | ACS ULTRA-1 THROMBOPLASTIN |
| Classification | Test, Time, Prothrombin |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers, IN 46038 |
| Contact | Pauline Bonderman |
| Correspondent | Pauline Bonderman ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers, IN 46038 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-22 |
| Decision Date | 1991-12-04 |