The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Diagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation Kit.
| Device ID | K063675 |
| 510k Number | K063675 |
| Device Name: | DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT |
| Classification | Antiserum, Fluorescent, Chlamydia Trachomatis |
| Applicant | DIAGNOSTIC HYBRIDS, INC. 350 WEST STATE ST. Athens, OH 45701 |
| Contact | Gail Goodrum |
| Correspondent | Gail Goodrum DIAGNOSTIC HYBRIDS, INC. 350 WEST STATE ST. Athens, OH 45701 |
| Product Code | LJP |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-11 |
| Decision Date | 2007-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613330554 | K063675 | 000 |
| 30014613330547 | K063675 | 000 |