DADE COLORIMETRIC AMYLASE— 510(k) K813529
Substantially EquivalentAmerican Dade
FDA 510(k) clearance K813529 for DADE COLORIMETRIC AMYLASE, Substantially Equivalent on 1981-12-31. Applicant: American Dade. Device class: 2.
Clearance details
- Applicant
- American Dade
- Product code
- Code CIJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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