ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43— 510(k) K914464
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K914464 for ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43, Substantially Equivalent on 1991-11-22. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Em Diagnostic Systems, Inc.
- Product code
- Code CKA
- Device class
- Class 1
- Regulation
- 21 CFR 862.1030
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gibbstown, NJ, US
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