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FDA 510(k)

EKTACHEM DT LDL CHOLESTEROL KIT

K-Number: K955904 · 1996-05-24

ApplicantJohnson & Johnson Clinical Diagnostics, Inc.
Decision Date1996-05-24
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EKTACHEM DT LDL CHOLESTEROL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-05-24 under 510(k) number K955904. The device is classified under product code MRR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EKTACHEM DT LDL CHOLESTEROL KIT?

EKTACHEM DT LDL CHOLESTEROL KIT is a medical device that received FDA 510(k) clearance on 1996-05-24. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. The 510(k) number is K955904.

When did EKTACHEM DT LDL CHOLESTEROL KIT receive FDA 510(k) clearance?

EKTACHEM DT LDL CHOLESTEROL KIT received FDA 510(k) clearance on 1996-05-24, under 510(k) number K955904.

Who is the listed applicant for EKTACHEM DT LDL CHOLESTEROL KIT?

The FDA 510(k) record lists Johnson & Johnson Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EKTACHEM DT LDL CHOLESTEROL KIT?

The FDA product code for EKTACHEM DT LDL CHOLESTEROL KIT is MRR.

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Other records listing Johnson & Johnson Clinical Diagnostics, Inc. as applicant

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Related Devices (Code: MRR)

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.

K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.K210801AXINON® LDL-p Test SystemNumares AGK161691Direct LDL Cholesterol (LDL)Randox Laboratories LimitedK091333S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022Alfa Wassermann, Inc.K090734EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTESMedica Corp.K063841NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLSLiposcience

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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