COXSACKIE A2 CF ANTIGEN, A4, A10 & A16
FDA 510(k) clearance K853279 · decided 1985-11-07
Clearance details
- K-number
- K853279
- Device name
- COXSACKIE A2 CF ANTIGEN, A4, A10 & A16
- Applicant
- Hillcrest Biologicals
- Decision
- Substantially Equivalent
- Date received
- 1985-08-05
- Decision date
- 1985-11-07
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- GNO
- Device class
- 1
- Regulation number
- 866.3145
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cypress, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.