The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Therapeutic Drug Monitoring Control, Level Ii.
| Device ID | K911177 |
| 510k Number | K911177 |
| Device Name: | ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers, IN 46038 |
| Contact | Pauline W Bonderman |
| Correspondent | Pauline W Bonderman ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers, IN 46038 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-18 |
| Decision Date | 1991-05-01 |