IMMULISA INTRINSIC FACTOR ANTIBODY ELISA— 510(k) K071346
Substantially EquivalentImmco Diagnostics, Inc.
FDA 510(k) clearance K071346 for IMMULISA INTRINSIC FACTOR ANTIBODY ELISA, Substantially Equivalent on 2007-09-24. Applicant: Immco Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Immco Diagnostics, Inc.
- Product code
- Code LIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1810
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buffalo, NY, US
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