COXSACKIE B SERIES CF ANTIGENS
FDA 510(k) clearance K850003 · decided 1985-03-05
Clearance details
- K-number
- K850003
- Device name
- COXSACKIE B SERIES CF ANTIGENS
- Applicant
- Hillcrest Biologicals
- Decision
- Substantially Equivalent
- Date received
- 1985-01-02
- Decision date
- 1985-03-05
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- GNG
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| COXSACKIE VIRUS B1-B6 CF ANTIGENS (K921618) | Virion (U.S.), Inc. | 1992-06-29 |
Recalls involving this device
No recalls on record reference this clearance.