The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Activated Partial Thromboplastin Time Test.
| Device ID | K902556 |
| 510k Number | K902556 |
| Device Name: | ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST |
| Classification | Activated Partial Thromboplastin |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 9001 TECHNOLOGY DR. SUITE A Fishers, IN 46060 |
| Contact | Roy Speck |
| Correspondent | Roy Speck ANALYTICAL CONTROL SYSTEMS, INC. 9001 TECHNOLOGY DR. SUITE A Fishers, IN 46060 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-08 |
| Decision Date | 1990-08-06 |