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 I.
| Device ID | K893784 |
| 510k Number | K893784 |
| Device Name: | ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I |
| Classification | Plasma, Control, Normal |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 9001 TECHNOLOGY DR. SUITE A Fishers, IN 46060 |
| Contact | Pauline W Bonderman |
| Correspondent | Pauline W Bonderman ANALYTICAL CONTROL SYSTEMS, INC. 9001 TECHNOLOGY DR. SUITE A Fishers, IN 46060 |
| Product Code | GIZ |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-22 |
| Decision Date | 1989-06-23 |