SYNERMED ISE REAGENTS— 510(k) K962479
Substantially EquivalentSynermed, Inc.
FDA 510(k) clearance K962479 for SYNERMED ISE REAGENTS, Substantially Equivalent on 1997-03-03. Applicant: Synermed, Inc.. Device class: 2.
Clearance details
- Applicant
- Synermed, Inc.
- Product code
- Code CGZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1170
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Quebec, Canada, CA
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