IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3
FDA 510(k) clearance K981226 · decided 1998-09-28
Clearance details
- K-number
- K981226
- Device name
- IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3
- Applicant
- Dako Diagnostics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-03-24
- Decision date
- 1998-09-28
- Days to decision
- 188 days
- Clearance type
- Traditional
- Product code
- GQP
- Device class
- 1
- Regulation number
- 866.3400
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cambridgeshire, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT (K933575) | Symex Corp. | 1994-11-28 |
Recalls involving this device
No recalls on record reference this clearance.