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FDA 510(k)

INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1

K-Number: K990594 · 1999-04-14

ApplicantRoche Diagnostics Corp.
Decision Date1999-04-14
Product CodeDER
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 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 1999-04-14 under 510(k) number K990594. The device is classified under product code DER. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1?

INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 is a medical device that received FDA 510(k) clearance on 1999-04-14. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K990594.

When did INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 receive FDA 510(k) clearance?

INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 received FDA 510(k) clearance on 1999-04-14, under 510(k) number K990594.

Who is the listed applicant for INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1?

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 INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1?

The FDA product code for INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 is DER.

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Other records listing Roche Diagnostics Corp. as applicant

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Related Devices (Code: DER)

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.

K013249TINA-QUANT APOLIPOPROTEIN VER.2Roche Diagnostics Corp.K000921BAYER ADVIA IMS SYSTEM; 200 + 3Bayer Corp.K993354K-ASSAY APO BKamiya Biomedical Co.K993345K-ASSAY APO AIKamiya Biomedical Co.K983289APOLIPOPROTEIN A1Abbott LaboratoriesK964292N-ASSAY TIA APO A1 TEST KITCrestat Diagnostics, 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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