FDA 510(k)

S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE

K-Number: K132462 · 2013-10-28

ApplicantHitachi Chemical Diagnostics, Inc.

Decision Date2013-10-28

Product CodeCDN

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE 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 2013-10-28 under 510(k) number K132462. The device is classified under product code CDN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE?

S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE is a medical device that received FDA 510(k) clearance on 2013-10-28. The listed applicant is Hitachi Chemical Diagnostics, Inc.. The 510(k) number is K132462.

When did S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE receive FDA 510(k) clearance?

S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE received FDA 510(k) clearance on 2013-10-28, under 510(k) number K132462.

Who is the listed applicant for S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE?

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 S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE?

The FDA product code for S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE is CDN.

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Related Devices (Code: CDN)

K190326VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc.K123322ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENTAlfa Wassermann Diagnostics Technologies, LLC K113389ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K103615ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARDAlfa Wassermann Diagnostic Technologies, Inc.K001885VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1Ortho-Clinical Diagnostics, Inc.K972012CHOLESTECH BUN/CREATININE TEST SYSTEMCholestech Corp.

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.