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FDA 510(k)

ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801

K-Number: K072638 · 2007-10-19

ApplicantRoche Diagnostics Corp.
Decision Date2007-10-19
Product CodeJGQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2007-10-19 under 510(k) number K072638. 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 ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801?

ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 is a medical device that received FDA 510(k) clearance on 2007-10-19. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K072638.

When did ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 receive FDA 510(k) clearance?

ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 received FDA 510(k) clearance on 2007-10-19, under 510(k) number K072638.

Who is the listed applicant for ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801?

The FDA product code for ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 is JGQ.

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Other records listing Roche Diagnostics Corp. as applicant

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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.

K131051HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)Hitachi Chemical Diagnostics, Inc.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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