The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Therapeutic Drug Monit Contols, Level I,ii,iii.
| Device ID | K913677 |
| 510k Number | K913677 |
| Device Name: | ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III |
| Classification | Drug Specific 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 | LAS |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-19 |
| Decision Date | 1991-09-25 |