FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY— 510(k) K860027
Substantially EquivalentAlerchek, Inc.
FDA 510(k) clearance K860027 for FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY, Substantially Equivalent on 1986-04-22. Applicant: Alerchek, Inc..
Clearance details
- Applicant
- Alerchek, Inc.
- Product code
- Code DHB
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, ME, US
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