K943099 is an FDA 510(k) clearance for the URINARY CATECHOLAMINE KIT. This device is classified as a Chromatographic/fluorometric Method, Catecholamines (Class I - General Controls, product code CHQ).
Submitted by Bioanalytical Systems, Inc. (West Lafayette, US). The FDA issued a Cleared decision on October 7, 1994, 100 days after receiving the submission on June 29, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1165.
| 510(k) Number | K943099 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 1994 |
| Decision Date | October 07, 1994 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CHQ — Chromatographic/fluorometric Method, Catecholamines |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1165 |