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FDA 510(k)

ALERT A,HDL-APOLIPOROTEIN A, TEST KIT

K-Number: K802610 · 1981-01-05

ApplicantHyland Therapeutic Div., Travenol Laboratories
Decision Date1981-01-05
Product CodeDER
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALERT A,HDL-APOLIPOROTEIN A, TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. It received FDA 510(k) clearance on 1981-01-05 under 510(k) number K802610. 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 ALERT A,HDL-APOLIPOROTEIN A, TEST KIT?

ALERT A,HDL-APOLIPOROTEIN A, TEST KIT is a medical device that received FDA 510(k) clearance on 1981-01-05. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. The 510(k) number is K802610.

When did ALERT A,HDL-APOLIPOROTEIN A, TEST KIT receive FDA 510(k) clearance?

ALERT A,HDL-APOLIPOROTEIN A, TEST KIT received FDA 510(k) clearance on 1981-01-05, under 510(k) number K802610.

Who is the listed applicant for ALERT A,HDL-APOLIPOROTEIN A, TEST KIT?

The FDA 510(k) record lists Hyland Therapeutic Div., Travenol Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALERT A,HDL-APOLIPOROTEIN A, TEST KIT?

The FDA product code for ALERT A,HDL-APOLIPOROTEIN A, TEST KIT is DER.

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Other records listing Hyland Therapeutic Div., Travenol Laboratories as applicant

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K820835ALUMINA SILICA-ACTIVATED PARTIAL THROMK820192HAEMOPHILUS INFLUENZAE TYPE B ANTISERUMK812220NEPHELOMETRIC SOLID TURBIDITY STANDARDK810078Q-PAK THERAPEUTIC DRUG MONIT. CONTROL SK810077OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.K791113LOW IONIC STRENGTH SOLUTION (LISS)

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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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