AMYLASE 405 CATALOG NUMBER 301-34— 510(k) K880867
Substantially EquivalentDiagnostic Chemicals, Ltd. (Usa)
FDA 510(k) clearance K880867 for AMYLASE 405 CATALOG NUMBER 301-34, Substantially Equivalent on 1988-04-19. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 2.
Clearance details
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monroe, CT, US
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