FLIPSCREEN (TM) TOTAL E IMMUNOASSAY— 510(k) K885307
Substantially EquivalentAlerchek, Inc.
FDA 510(k) clearance K885307 for FLIPSCREEN (TM) TOTAL E IMMUNOASSAY, Substantially Equivalent on 1989-03-08. Applicant: Alerchek, Inc.. Device class: 2.
Clearance details
- Applicant
- Alerchek, Inc.
- Product code
- Code DGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, ME, US
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