The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs 0.02 M Calcium Chloride.
| Device ID | K902458 |
| 510k Number | K902458 |
| Device Name: | ACS 0.02 M CALCIUM CHLORIDE |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers, IN 46038 |
| Contact | W Bonderman |
| Correspondent | W Bonderman ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers, IN 46038 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-04 |
| Decision Date | 1990-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817869020007 | K902458 | 000 |