COXSACKIE VIRUS B1-B6 CF ANTIGENS
FDA 510(k) clearance K921618 · decided 1992-06-29
Clearance details
- K-number
- K921618
- Device name
- COXSACKIE VIRUS B1-B6 CF ANTIGENS
- Applicant
- Virion (U.S.), Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-04-06
- Decision date
- 1992-06-29
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- GNG
- Device class
- 1
- Regulation number
- 866.3145
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Morristown, NJ, US
- 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 |
|---|---|---|
| COXSACKIE B SERIES CF ANTIGENS (K850003) | Hillcrest Biologicals | 1985-03-05 |
Recalls involving this device
No recalls on record reference this clearance.