SYSTEMATE TOTAL PROTEIN 67218— 510(k) K843107
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K843107 for SYSTEMATE TOTAL PROTEIN 67218, Substantially Equivalent on 1984-08-27. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Em Diagnostic Systems, Inc.
- Product code
- Code CEK
- Device class
- Class 2
- Regulation
- 21 CFR 862.1635
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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