The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for D3 Fastpoint L-dfa Parainfluenza Virus/adenovirus Identification Kit.
| Device ID | K093415 |
| 510k Number | K093415 |
| Device Name: | D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT |
| Classification | Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 |
| Applicant | DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
| Contact | Ronald H Lollar |
| Correspondent | Ronald H Lollar DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
| Product Code | GQS |
| CFR Regulation Number | 866.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-02 |
| Decision Date | 2009-12-23 |
| Summary: | summary |