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FDA 510(k)

LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR

K-Number: K971162 · 1997-06-16

ApplicantGenzyme Corp.
Decision Date1997-06-16
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corp.. It received FDA 510(k) clearance on 1997-06-16 under 510(k) number K971162. 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 LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR?

LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR is a medical device that received FDA 510(k) clearance on 1997-06-16. The listed applicant is Genzyme Corp.. The 510(k) number is K971162.

When did LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR receive FDA 510(k) clearance?

LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR received FDA 510(k) clearance on 1997-06-16, under 510(k) number K971162.

Who is the listed applicant for LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR?

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

What is the FDA product code for LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR?

The FDA product code for LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR is LBS.

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Other records listing Genzyme 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.

K061508OSOM INFLUENZA A&B TESTK051244GENZYME OSOM INFLUENZA A & B TESTK040241N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SETK040868SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESHK033864GENZYME OSOM TRICHOMONAS RAPID TESTK023544GENZYME CONTRAST II HCG URINE/SERUM TEST

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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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