The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Dfa Respiratory Virus Screening & Id Kit.
Device ID | K022713 |
510k Number | K022713 |
Device Name: | DFA RESPIRATORY VIRUS SCREENING & ID KIT |
Classification | Antisera, Cf, Influenza Virus A, B, C |
Applicant | DIAGNOSTIC HYBRIDS, INC. 350 WEST STATE ST. Athens, OH 45701 |
Contact | James L Brown |
Correspondent | James L Brown DIAGNOSTIC HYBRIDS, INC. 350 WEST STATE ST. Athens, OH 45701 |
Product Code | GNW |
CFR Regulation Number | 866.3330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-08-14 |
Decision Date | 2002-12-18 |
Summary: | summary |