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FDA 510(k)

PBI PLUS HDL PRECIPITATING REAGENT

K-Number: K941744 · 1994-09-06

ApplicantMerchant House Scientific
Decision Date1994-09-06
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PBI PLUS HDL PRECIPITATING REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Merchant House Scientific. It received FDA 510(k) clearance on 1994-09-06 under 510(k) number K941744. 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 PBI PLUS HDL PRECIPITATING REAGENT?

PBI PLUS HDL PRECIPITATING REAGENT is a medical device that received FDA 510(k) clearance on 1994-09-06. The listed applicant is Merchant House Scientific. The 510(k) number is K941744.

When did PBI PLUS HDL PRECIPITATING REAGENT receive FDA 510(k) clearance?

PBI PLUS HDL PRECIPITATING REAGENT received FDA 510(k) clearance on 1994-09-06, under 510(k) number K941744.

Who is the listed applicant for PBI PLUS HDL PRECIPITATING REAGENT?

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

What is the FDA product code for PBI PLUS HDL PRECIPITATING REAGENT?

The FDA product code for PBI PLUS HDL PRECIPITATING REAGENT is LBR.

Related Clinical Trials

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.

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Other records listing Merchant House Scientific 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.

K934961SPINPRO HDL PRECIPITATING REAGENTK934801SPINPRO HDL PRECIPITATING REAGENT

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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