REVISED MAGNESIUM TEST ITEM NUMBER: SR1019— 510(k) K890798
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K890798 for REVISED MAGNESIUM TEST ITEM NUMBER: SR1019, Substantially Equivalent on 1989-03-31. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Em Diagnostic Systems, Inc.
- Product code
- Code JGJ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1495
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gibbstown, NJ, US
Recent devices under product code JGJ
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