510(k) K913828
- Device
- Qtest Influenza A
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K913828
- Product code
- GNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-09-23
- Date received
- 1991-08-26
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- J ARNSBERGER
- Address
- 1 Becton Dr. Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 3013530901
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GNT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950838 | VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES | Zymetx, Inc. | 1996-06-17 |
| 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 |