The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Specktin-la Test Set.
| Device ID | K961892 |
| 510k Number | K961892 |
| Device Name: | SPECKTIN-LA TEST SET |
| Classification | Activated Partial Thromboplastin |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers, IN 46038 |
| Contact | Pauline W Bonderman |
| Correspondent | Pauline W Bonderman ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers, IN 46038 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-16 |
| Decision Date | 1997-03-07 |