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FDA 510(k)

ROCHE COBAS AMPLICOR ANALYZER

K-Number: K964506 · 1997-05-21

ApplicantRoche Molecular Systems, Inc.
Decision Date1997-05-21
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE COBAS AMPLICOR ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 1997-05-21 under 510(k) number K964506. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE COBAS AMPLICOR ANALYZER?

ROCHE COBAS AMPLICOR ANALYZER is a medical device that received FDA 510(k) clearance on 1997-05-21. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K964506.

When did ROCHE COBAS AMPLICOR ANALYZER receive FDA 510(k) clearance?

ROCHE COBAS AMPLICOR ANALYZER received FDA 510(k) clearance on 1997-05-21, under 510(k) number K964506.

Who is the listed applicant for ROCHE COBAS AMPLICOR ANALYZER?

The FDA 510(k) record lists Roche Molecular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROCHE COBAS AMPLICOR ANALYZER?

The FDA product code for ROCHE COBAS AMPLICOR ANALYZER is JJF.

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Related Devices (Code: JJF)

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.

K052794ETI-MAX 3000DiaSorin, Inc.K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERArkray, Inc.K033734LIGHTCYCLER INSTRUMENT VERSION 1.2Roche Diagnostics Corp.K013654PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZERPrecision Systems, Inc.K012966ROCHE COBAS TAQMAN ANALYZERRoche Molecular Systems, Inc.K993634CARESIDE ANALYZERCareside, Inc.

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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