S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE— 510(k) K132462

Substantially Equivalent

Hitachi 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..

Clearance details

Applicant: Hitachi Chemical Diagnostics, Inc.
Product code: Code CDN
Advisory panel: Clinical Chemistry
Date received: 2013-08-07
Decision date: 2013-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

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