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FDA 510(k)

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)

K-Number: K130870 · 2013-05-02

ApplicantHitachi Chemical Diagnostics, Inc.
Decision Date2013-05-02
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Chemical Diagnostics, Inc.. It received FDA 510(k) clearance on 2013-05-02 under 510(k) number K130870. The device is classified under product code CIC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)?

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) is a medical device that received FDA 510(k) clearance on 2013-05-02. The listed applicant is Hitachi Chemical Diagnostics, Inc.. The 510(k) number is K130870.

When did HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) receive FDA 510(k) clearance?

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) received FDA 510(k) clearance on 2013-05-02, under 510(k) number K130870.

Who is the listed applicant for HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)?

The FDA 510(k) record lists Hitachi Chemical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)?

The FDA product code for HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) is CIC.

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Other records listing Hitachi Chemical Diagnostics, Inc. as applicant

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Related Devices (Code: CIC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K083339DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)Siemens Healthcare Diagnostics, Inc.K070249ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/HHoriba AbxK053401SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTSArkray, Inc.K050077SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTSArkray, Inc.K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTHemagen Diagnostics, Inc.K023105ATAC CALCIUM REAGENT AND ATAC CALIBRATORElan Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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