The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Apct Reagent, Modified.
| Device ID | K926012 |
| 510k Number | K926012 |
| Device Name: | ACS APCT REAGENT, MODIFIED |
| Classification | Activated Partial Thromboplastin |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers, IN 46038 |
| Contact | Roy Speck |
| Correspondent | Roy Speck 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 | 1992-11-20 |
| Decision Date | 1993-04-27 |