CHEM-STRATE AMYLASE— 510(k) K792479
Substantially EquivalentGeneral Diagnostics
FDA 510(k) clearance K792479 for CHEM-STRATE AMYLASE, Substantially Equivalent on 1979-12-27. Applicant: General Diagnostics. Device class: 2.
Clearance details
- Applicant
- General Diagnostics
- 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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