CRYPTOCOCCUS NEOFORMANS, ANTIGEN,
FDA 510(k) clearance K792691 · decided 1980-01-17
Clearance details
- K-number
- K792691
- Device name
- CRYPTOCOCCUS NEOFORMANS, ANTIGEN,
- Applicant
- Meridian Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-12-27
- Decision date
- 1980-01-17
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- JWK
- Device class
- 2
- Regulation number
- 866.3165
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.