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FDA 510(k)

DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO

K-Number: K792183 · 1979-11-13

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1979-11-13
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-11-13 under 510(k) number K792183. The device is classified under product code LBS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO?

DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO is a medical device that received FDA 510(k) clearance on 1979-11-13. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K792183.

When did DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO receive FDA 510(k) clearance?

DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO received FDA 510(k) clearance on 1979-11-13, under 510(k) number K792183.

Who is the listed applicant for DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO?

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

What is the FDA product code for DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO?

The FDA product code for DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO is LBS.

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Related Devices (Code: LBS)

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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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