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FDA 510(k)

APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1

K-Number: K851649 · 1985-06-05

ApplicantPhotec Diagnostics, Inc.
Decision Date1985-06-05
Product CodeDER
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 is the device name listed in this FDA 510(k) record. The listed applicant is Photec Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-06-05 under 510(k) number K851649. 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 APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1?

APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 is a medical device that received FDA 510(k) clearance on 1985-06-05. The listed applicant is Photec Diagnostics, Inc.. The 510(k) number is K851649.

When did APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 receive FDA 510(k) clearance?

APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 received FDA 510(k) clearance on 1985-06-05, under 510(k) number K851649.

Who is the listed applicant for APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1?

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

What is the FDA product code for APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1?

The FDA product code for APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 is DER.

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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.K990594INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1Roche Diagnostics Corp.K983289APOLIPOPROTEIN A1Abbott Laboratories

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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