The following data is part of a premarket notification filed by Serono Diagnostics, Inc. with the FDA for Monabrite Chlamydia Trachomatis Dir. Specimen Test.
| Device ID | K870946 |
| 510k Number | K870946 |
| Device Name: | MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST |
| Classification | Antiserum, Fluorescent, Chlamydia Trachomatis |
| Applicant | SERONO DIAGNOSTICS, INC. 100 LONGWATER CIRCLE Norwell, MA 02061 |
| Contact | Philip M Fantasia |
| Correspondent | Philip M Fantasia SERONO DIAGNOSTICS, INC. 100 LONGWATER CIRCLE Norwell, MA 02061 |
| Product Code | LJP |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-09 |
| Decision Date | 1987-04-29 |