EMDS(TM) CALCIUM TESTPACKS, #67687/95— 510(k) K863003
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K863003 for EMDS(TM) CALCIUM TESTPACKS, #67687/95, Substantially Equivalent on 1986-09-16. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Em Diagnostic Systems, Inc.
- Product code
- Code CIC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gibbstown, NJ, US
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