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FDA 510(k)

LAS-R BETA LIPOPROTEIN TEST

K-Number: K771912 · 1977-10-19

ApplicantHyland Therapeutic Div., Travenol Laboratories
Decision Date1977-10-19
Product CodeDFC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LAS-R BETA LIPOPROTEIN TEST 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 1977-10-19 under 510(k) number K771912. The device is classified under product code DFC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAS-R BETA LIPOPROTEIN TEST?

LAS-R BETA LIPOPROTEIN TEST is a medical device that received FDA 510(k) clearance on 1977-10-19. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. The 510(k) number is K771912.

When did LAS-R BETA LIPOPROTEIN TEST receive FDA 510(k) clearance?

LAS-R BETA LIPOPROTEIN TEST received FDA 510(k) clearance on 1977-10-19, under 510(k) number K771912.

Who is the listed applicant for LAS-R BETA LIPOPROTEIN TEST?

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 LAS-R BETA LIPOPROTEIN TEST?

The FDA product code for LAS-R BETA LIPOPROTEIN TEST is DFC.

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Related Devices (Code: DFC)

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.

K253069Lipoprotein (a) Molarity AssayDiazyme Laboratories, Inc.K241220Tina-quant Lipoprotein(a) Gen.2 MolarityRoche Diagnostics OperationsK211058Lp(a) UltraSENTINEL CH. SpAK180074Diazyme Lipoprotein (a) AssayDiazyme Laboratories, Inc.K123046ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATORSiemens Healthcare Diagnostics, Inc.K122722COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160Roche Diagnostics

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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