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FDA 510(k)

CHOL-HDL TEST, HIGH LIPO. CHOL TEST

K-Number: K792313 · 1979-12-07

ApplicantSclavo, Inc.
Decision Date1979-12-07
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOL-HDL TEST, HIGH LIPO. CHOL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1979-12-07 under 510(k) number K792313. The device is classified under product code LBR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHOL-HDL TEST, HIGH LIPO. CHOL TEST?

CHOL-HDL TEST, HIGH LIPO. CHOL TEST is a medical device that received FDA 510(k) clearance on 1979-12-07. The listed applicant is Sclavo, Inc.. The 510(k) number is K792313.

When did CHOL-HDL TEST, HIGH LIPO. CHOL TEST receive FDA 510(k) clearance?

CHOL-HDL TEST, HIGH LIPO. CHOL TEST received FDA 510(k) clearance on 1979-12-07, under 510(k) number K792313.

Who is the listed applicant for CHOL-HDL TEST, HIGH LIPO. CHOL TEST?

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

What is the FDA product code for CHOL-HDL TEST, HIGH LIPO. CHOL TEST?

The FDA product code for CHOL-HDL TEST, HIGH LIPO. CHOL TEST is LBR.

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Related Devices (Code: LBR)

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.

K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSGeneral AtomicsK050823DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATORTeco DiagnosticsK023784RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERHemagen Diagnostics, Inc.K012593VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2Ortho-Clinical Diagnostics, Inc.K992029ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSElan DiagnosticsK992002AUTOHDL CHOLESTEROL REAGENT SETPointe Scientific, Inc.,

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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