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FDA 510(k)

HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)

K-Number: K131051 · 2013-06-07

ApplicantHitachi Chemical Diagnostics, Inc.
Decision Date2013-06-07
Product CodeJGQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) 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 2013-06-07 under 510(k) number K131051. The device is classified under product code JGQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)?

HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) is a medical device that received FDA 510(k) clearance on 2013-06-07. The listed applicant is Hitachi Chemical Diagnostics, Inc.. The 510(k) number is K131051.

When did HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) receive FDA 510(k) clearance?

HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) received FDA 510(k) clearance on 2013-06-07, under 510(k) number K131051.

Who is the listed applicant for HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)?

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 S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)?

The FDA product code for HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) is JGQ.

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Related Devices (Code: JGQ)

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.

K072638ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801Roche Diagnostics Corp.K071239TOTAL PROTEIN URINE/CSF GEN.3Roche DiagnosticsK981295UPROAbbott LaboratoriesK981682UPROAbbott LaboratoriesK925794TRACE MICROPROTEIN REAGENTTrace America, Inc.K913615URINARY/CSF PROTEINBoehringer Mannheim 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.

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