QUANTECH MYOGLOBIN ASSAY— 510(k) K981536
Substantially EquivalentHellen Professional Services
FDA 510(k) clearance K981536 for QUANTECH MYOGLOBIN ASSAY, Substantially Equivalent on 1998-06-29. Applicant: Hellen Professional Services. Device class: 2.
Clearance details
- Applicant
- Hellen Professional Services
- Product code
- Code MVE
- Device class
- Class 2
- Regulation
- 21 CFR 866.5680
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northridge, CA, US
More clearances from Hellen Professional Services
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