MYOGLOBIN RIA TEST KIT
FDA 510(k) clearance K915233 · decided 1992-03-30
Clearance details
- K-number
- K915233
- Device name
- MYOGLOBIN RIA TEST KIT
- Applicant
- Pro Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-11-22
- Decision date
- 1992-03-30
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- DDR
- Device class
- 2
- Regulation number
- 866.5680
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.