DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D— 510(k) K093357
Substantially EquivalentDiamond Diagnostics, Inc.
FDA 510(k) clearance K093357 for DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D, Substantially Equivalent on 2010-06-24. Applicant: Diamond Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Diamond Diagnostics, Inc.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Holliston, MA, US
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