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FDA 510(k)

APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1

K-Number: K853048 · 1985-08-28

ApplicantPhotec Diagnostics, Inc.
Decision Date1985-08-28
Product CodeDER
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 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 1985-08-28 under 510(k) number K853048. 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-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1?

APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 is a medical device that received FDA 510(k) clearance on 1985-08-28. The listed applicant is Photec Diagnostics, Inc.. The 510(k) number is K853048.

When did APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 receive FDA 510(k) clearance?

APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 received FDA 510(k) clearance on 1985-08-28, under 510(k) number K853048.

Who is the listed applicant for APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1?

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-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1?

The FDA product code for APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 is DER.

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Other records listing Photec Diagnostics, Inc. 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.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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