ECHO TYPE 4 CF ANTIGEN
FDA 510(k) clearance K844695 · decided 1985-03-05
Clearance details
- K-number
- K844695
- Device name
- ECHO TYPE 4 CF ANTIGEN
- Applicant
- Hillcrest Biologicals
- Decision
- Substantially Equivalent
- Date received
- 1984-12-03
- Decision date
- 1985-03-05
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- GNL
- Device class
- 1
- Regulation number
- 866.3205
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Long Beach, 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 9 CF ANTIGEN (K844967) | Hillcrest Biologicals | 1985-03-05 |
Recalls involving this device
No recalls on record reference this clearance.