INFLUENZA B ANITGEN TEST
FDA 510(k) clearance K942174 · decided 1994-06-30
Clearance details
- K-number
- K942174
- Device name
- INFLUENZA B ANITGEN TEST
- Applicant
- Neogenex
- Decision
- Substantially Equivalent
- Date received
- 1994-05-05
- Decision date
- 1994-06-30
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- GNW
- Device class
- 1
- Regulation number
- 866.3330
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Everett, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.