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FDA 510(k)

STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE

K-Number: K890669 · 1989-03-08

ApplicantNorfolk Scientific, Inc.
Decision Date1989-03-08
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Norfolk Scientific, Inc.. It received FDA 510(k) clearance on 1989-03-08 under 510(k) number K890669. 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 STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE?

STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE is a medical device that received FDA 510(k) clearance on 1989-03-08. The listed applicant is Norfolk Scientific, Inc.. The 510(k) number is K890669.

When did STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE receive FDA 510(k) clearance?

STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE received FDA 510(k) clearance on 1989-03-08, under 510(k) number K890669.

Who is the listed applicant for STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE?

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

What is the FDA product code for STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE?

The FDA product code for STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE is LBR.

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Other records listing Norfolk Scientific, 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.

K902028STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READERK883185SAFECRIT PLASTIC MICROHEMATOCRIT TUBESK881254STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01K870511CHART-TYPE MICRO HEMATOCRIT TUBE READERK864974GENERAL PURPOSE CENTRIFUGEK860172QWIKSPIN (TM)

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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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