The following data is part of a premarket notification filed by Tri-tech, Inc. with the FDA for Tri-tech Urine Specimen Kit.
| Device ID | K900983 |
| 510k Number | K900983 |
| Device Name: | TRI-TECH URINE SPECIMEN KIT |
| Classification | Container, Specimen, Sterile |
| Applicant | TRI-TECH, INC. 8904 PADDOCK LN. Potomac, MD 20854 |
| Contact | Bernard L Konopko |
| Correspondent | Bernard L Konopko TRI-TECH, INC. 8904 PADDOCK LN. Potomac, MD 20854 |
| Product Code | FMH |
| CFR Regulation Number | 864.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-02 |
| Decision Date | 1990-09-17 |