VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT
FDA 510(k) clearance K933575 · decided 1994-11-28
Clearance details
- K-number
- K933575
- Device name
- VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT
- Applicant
- Symex Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-23
- Decision date
- 1994-11-28
- Days to decision
- 493 days
- Clearance type
- Traditional
- Product code
- GQP
- Device class
- 1
- Regulation number
- 866.3400
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Tulsa, OK, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Symex Corp.
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 |
|---|---|---|
| IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 (K981226) | Dako Diagnostics , Ltd. | 1998-09-28 |
Recalls involving this device
No recalls on record reference this clearance.