S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE— 510(k) K132462
Substantially EquivalentHitachi Chemical Diagnostics, Inc.
FDA 510(k) clearance K132462 for S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE, Substantially Equivalent on 2013-10-28. Applicant: Hitachi Chemical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Hitachi Chemical Diagnostics, Inc.
- Product code
- Code CDN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
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