The following data is part of a premarket notification filed by Doxtech, Inc. with the FDA for Dox Tamperproof Specimen Container System.
| Device ID | K913967 |
| 510k Number | K913967 |
| Device Name: | DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM |
| Classification | Container, Specimen Mailer And Storage, Temperature Controlled, Sterile |
| Applicant | DOXTECH, INC. 4000 EASTON DR., #10 Bakersfield, CA 93309 |
| Contact | Stanley D Ogden |
| Correspondent | Stanley D Ogden DOXTECH, INC. 4000 EASTON DR., #10 Bakersfield, CA 93309 |
| Product Code | KDW |
| CFR Regulation Number | 864.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-05 |
| Decision Date | 1991-10-18 |