The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Freeze-dried Aptt Reagent.
| Device ID | K921223 |
| 510k Number | K921223 |
| Device Name: | ACS FREEZE-DRIED APTT REAGENT |
| Classification | Activated Partial Thromboplastin |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 155 E. MARKET, SUITE 502 Indianapolis, IN 46204 |
| Contact | Pauline Bondermann |
| Correspondent | Pauline Bondermann ANALYTICAL CONTROL SYSTEMS, INC. 155 E. MARKET, SUITE 502 Indianapolis, IN 46204 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-13 |
| Decision Date | 1992-08-18 |