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FDA 510(k)

TECHNICON HDL CHOLESTEROL METHOD

K-Number: K791990 · 1979-10-17

ApplicantTechnicon Instruments Corp.
Decision Date1979-10-17
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TECHNICON HDL CHOLESTEROL METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1979-10-17 under 510(k) number K791990. 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 TECHNICON HDL CHOLESTEROL METHOD?

TECHNICON HDL CHOLESTEROL METHOD is a medical device that received FDA 510(k) clearance on 1979-10-17. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K791990.

When did TECHNICON HDL CHOLESTEROL METHOD receive FDA 510(k) clearance?

TECHNICON HDL CHOLESTEROL METHOD received FDA 510(k) clearance on 1979-10-17, under 510(k) number K791990.

Who is the listed applicant for TECHNICON HDL CHOLESTEROL METHOD?

The FDA 510(k) record lists Technicon Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECHNICON HDL CHOLESTEROL METHOD?

The FDA product code for TECHNICON HDL CHOLESTEROL METHOD is LBS.

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Other records listing Technicon Instruments Corp. as applicant

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.

K914888TECHNICON CHEM 1(TM) SYST (GEN2 SYST)K914511TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOLK914025TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)K912616TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTESK912413CHEM-LINK DATA BASE MANAGERK903824DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY

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Related Devices (Code: LBS)

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.

K162593HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo)K153435Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd.K120609VITROS CHEMISTRY PRODUCTS DHDL SLIDESOrtho-Clinical Diagnostics, Inc.K111516NMR LIPOPROFILE (R) TEST AND NMR PROFILERLiposcience, Inc.K103747ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYSElitechgroup Seppim S.A.S.K111036EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENTMedica Corporation

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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