GLUCOSE-HK TEST (GLU-HK) ITEM #65415— 510(k) K894483
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K894483 for GLUCOSE-HK TEST (GLU-HK) ITEM #65415, Substantially Equivalent on 1989-09-07. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Em Diagnostic Systems, Inc.
- Product code
- Code CFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gibbstown, NJ, US
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