ECHO TYPE 30 CF ANTIGEN
FDA 510(k) clearance K853165 · decided 1985-11-07
Clearance details
- K-number
- K853165
- Device name
- ECHO TYPE 30 CF ANTIGEN
- Applicant
- Hillcrest Biologicals
- Decision
- Substantially Equivalent
- Date received
- 1985-07-30
- Decision date
- 1985-11-07
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- GNK
- Device class
- 1
- Regulation number
- 866.3205
- 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 |
|---|---|---|
| ECHO TYPE 16 CF ANTIGEN (K853156) | Hillcrest Biologicals | 1985-11-07 |
| ECHO TYPE 11 CF ANTIGEN (K853157) | Hillcrest Biologicals | 1985-11-07 |
Recalls involving this device
No recalls on record reference this clearance.