The following data is part of a premarket notification filed by Bio-analysis, Inc. with the FDA for Pantex Salivary Direct Testosterone Eia Kit, Pantex Sample Collection Device.
| Device ID | K133303 |
| 510k Number | K133303 |
| Device Name: | PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BIO-ANALYSIS, INC. 27735 TAMARA DRIVE Yorba Linda, CA 92887 |
| Contact | Regina J O'meara |
| Correspondent | Regina J O'meara BIO-ANALYSIS, INC. 27735 TAMARA DRIVE Yorba Linda, CA 92887 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-25 |
| Decision Date | 2014-11-19 |
| Summary: | summary |