The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for D3 Dfa Cytomegalovirus Immediate Early Antigen Identification Kit.
| Device ID | K081164 |
| 510k Number | K081164 |
| Device Name: | D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT |
| Classification | Antisera, Conjugated Fluorescent, Cytomegalovirus |
| Applicant | DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
| Contact | Gail R Goodrum |
| Correspondent | Gail R Goodrum DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
| Product Code | LIN |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-24 |
| Decision Date | 2008-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613330677 | K081164 | 000 |
| 30014613330660 | K081164 | 000 |