EASY-TEST AMLASE (AMYL), #67521/93— 510(k) K860918
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K860918 for EASY-TEST AMLASE (AMYL), #67521/93, Substantially Equivalent on 1986-04-03. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Em Diagnostic Systems, Inc.
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gibbstown, NJ, US
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