K952246 is an FDA 510(k) clearance for the TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT. This device is classified as a Kit, Screening, Urine (Class I - General Controls, product code JXA).
Submitted by Tri-Tech, Inc. (Southport, US). The FDA issued a Cleared decision on June 20, 1995, 39 days after receiving the submission on May 12, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K952246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 1995 |
| Decision Date | June 20, 1995 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JXA — Kit, Screening, Urine |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |