K941115 is an FDA 510(k) clearance for the ACS CARDIO-TROL CONTROL. This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I - General Controls, product code JJY).
Submitted by Analytical Control Systems, Inc. (Fishers, US). The FDA issued a Cleared decision on July 20, 1994, 135 days after receiving the submission on March 7, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K941115 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1994 |
| Decision Date | July 20, 1994 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JJY — Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |