510(k) K950838
- Device
- VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES
- Applicant
- ZYMETX, INC.
- 510(k) number
- K950838
- Product code
- GNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-06-17
- Date received
- 1995-02-24
- Regulation
- 866.3330
- Classification name
- Antigens, Ha (including Ha Control), Influenza Virus A, B, C
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CRAIG D SHIMASAKI
- Address
- 25 Northwest 4th St. Oklahoma City OK US 73102 73102
FDA Registration Numbers#
- 3013530901
Source Documents#
Other 510(k) Records For Product Code GNT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K913828 | QTEST INFLUENZA A | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-09-23 |
| K902609 | DIRECTIGEN FLU A | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-09-10 |
| K780272 | INFLUENZA HA ANTIGEN | Flow Laboratories, Inc. | 1978-02-28 |
| K780275 | INFLUENZA HA ANTIGEN A/USSR | Flow Laboratories, Inc. | 1978-02-28 |
Legacy Summary#
summary
FDA Review#
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