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FDA 510(k)

BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL

K-Number: K970735 · 1997-06-06

ApplicantRandox Laboratories, Ltd.
Decision Date1997-06-06
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 1997-06-06 under 510(k) number K970735. 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 BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL?

BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1997-06-06. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K970735.

When did BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL receive FDA 510(k) clearance?

BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL received FDA 510(k) clearance on 1997-06-06, under 510(k) number K970735.

Who is the listed applicant for BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL?

The FDA 510(k) record lists Randox Laboratories, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL?

The FDA product code for BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL is LBS.

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Other records listing Randox Laboratories, Ltd. 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.

K230890ISE ElectrodesK182042Randox Calcium (Ca)K162200Randox RX Daytona Plus Magnesium (MG)K152085Liquid CO2-2 (LCO2-2)K153435Direct HDL Cholesterol (HDL)K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

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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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