VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES
FDA 510(k) clearance K950838 · decided 1996-06-17
Clearance details
- K-number
- K950838
- Device name
- VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES
- Applicant
- Zymetx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-24
- Decision date
- 1996-06-17
- Days to decision
- 479 days
- Clearance type
- Traditional
- Product code
- GNT
- Device class
- 1
- Regulation number
- 866.3330
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Oklahoma City, OK, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Zymetx
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| QTEST INFLUENZA A (K913828) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-09-23 |
| DIRECTIGEN FLU A (K902609) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-09-10 |
| INFLUENZA HA ANTIGEN (K780272) | Flow Laboratories, Inc. | 1978-02-28 |
| INFLUENZA HA ANTIGEN A/USSR (K780275) | Flow Laboratories, Inc. | 1978-02-28 |
Recalls involving this device
No recalls on record reference this clearance.