K900983 is an FDA 510(k) clearance for the TRI-TECH URINE SPECIMEN KIT. This device is classified as a Container, Specimen, Sterile (Class I - General Controls, product code FMH).
Submitted by Tri-Tech, Inc. (Potomac, US). The FDA issued a Cleared decision on September 17, 1990, 199 days after receiving the submission on March 2, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.3250.
| 510(k) Number | K900983 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 1990 |
| Decision Date | September 17, 1990 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | FMH — Container, Specimen, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3250 |