The following data is part of a premarket notification filed by Serono Diagnostics, Inc. with the FDA for Monabrite Chlamydia Trach Culture Confirmation Tes.
| Device ID | K854615 |
| 510k Number | K854615 |
| Device Name: | MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES |
| Classification | Antisera, Fluorescent, Chlamydia Spp. |
| Applicant | SERONO DIAGNOSTICS, INC. 11 BROOKS DR. Braintree, MA 02184 |
| Contact | Lawlor, Ph.d. |
| Correspondent | Lawlor, Ph.d. SERONO DIAGNOSTICS, INC. 11 BROOKS DR. Braintree, MA 02184 |
| Product Code | LKI |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-18 |
| Decision Date | 1986-01-28 |