The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Therapeutic Drug Monitoring Control Set I Le.1.
| Device ID | K910930 |
| 510k Number | K910930 |
| Device Name: | ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1 |
| Classification | Drug Mixture Control Materials |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 155 E. MARKET, SUITE 502 Indianapolis, IN 46204 |
| Contact | Pauline W Bonderman |
| Correspondent | Pauline W Bonderman ANALYTICAL CONTROL SYSTEMS, INC. 155 E. MARKET, SUITE 502 Indianapolis, IN 46204 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-06 |
| Decision Date | 1991-05-01 |