The following data is part of a premarket notification filed by Neogenex with the FDA for Chlamydia Trachomatis Antigen Test.
| Device ID | K941714 |
| 510k Number | K941714 |
| Device Name: | CHLAMYDIA TRACHOMATIS ANTIGEN TEST |
| Classification | Antiserum, Fluorescent, Chlamydia Trachomatis |
| Applicant | NEOGENEX 12811 EIGHT AVENUE WEST SUITE A-101 Everett, WA 98204 |
| Contact | D. F Roberts |
| Correspondent | D. F Roberts NEOGENEX 12811 EIGHT AVENUE WEST SUITE A-101 Everett, WA 98204 |
| Product Code | LJP |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-23 |
| Decision Date | 1994-07-18 |