TANARAMA
FDA 510(k) clearance K812603 · decided 1981-11-20
Clearance details
- K-number
- K812603
- Device name
- TANARAMA
- Applicant
- Marketing Consultants of America
- Decision
- Substantially Equivalent
- Date received
- 1981-09-15
- Decision date
- 1981-11-20
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- GGG
- Device class
- 2
- Regulation number
- 864.6550
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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.