QUANTECH MYOGLOBIN ASSAY
FDA 510(k) clearance K981536 · decided 1998-06-29
Clearance details
- K-number
- K981536
- Device name
- QUANTECH MYOGLOBIN ASSAY
- Applicant
- Hellen Professional Services
- Decision
- Substantially Equivalent
- Date received
- 1998-04-29
- Decision date
- 1998-06-29
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- MVE
- Device class
- 2
- Regulation number
- 866.5680
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Northridge, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.