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FDA 510(k)

COULTER HDL CHOLESTEROL REAG. SYSTEM

K-Number: K792319 · 1979-12-06

ApplicantCoulter Electronics, Inc.
Decision Date1979-12-06
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COULTER HDL CHOLESTEROL REAG. SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1979-12-06 under 510(k) number K792319. 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 COULTER HDL CHOLESTEROL REAG. SYSTEM?

COULTER HDL CHOLESTEROL REAG. SYSTEM is a medical device that received FDA 510(k) clearance on 1979-12-06. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K792319.

When did COULTER HDL CHOLESTEROL REAG. SYSTEM receive FDA 510(k) clearance?

COULTER HDL CHOLESTEROL REAG. SYSTEM received FDA 510(k) clearance on 1979-12-06, under 510(k) number K792319.

Who is the listed applicant for COULTER HDL CHOLESTEROL REAG. SYSTEM?

The FDA 510(k) record lists Coulter Electronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COULTER HDL CHOLESTEROL REAG. SYSTEM?

The FDA product code for COULTER HDL CHOLESTEROL REAG. SYSTEM is LBS.

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Other records listing Coulter Electronics, Inc. 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.

K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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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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