The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Human Plasma Coagulation Control Level Iii.
| Device ID | K894425 |
| 510k Number | K894425 |
| Device Name: | ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III |
| Classification | Control, Plasma, Abnormal |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 155 E. MARKET, SUITE 502 Indianapolis, IN 46204 |
| Contact | W Bonderman |
| Correspondent | W Bonderman ANALYTICAL CONTROL SYSTEMS, INC. 155 E. MARKET, SUITE 502 Indianapolis, IN 46204 |
| Product Code | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-08-03 |