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FDA 510(k)

SPINPRO HDL PRECIPITATING REAGENT

K-Number: K934961 · 1993-12-09

ApplicantMerchant House Scientific
Decision Date1993-12-09
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPINPRO 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 1993-12-09 under 510(k) number K934961. 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 SPINPRO HDL PRECIPITATING REAGENT?

SPINPRO HDL PRECIPITATING REAGENT is a medical device that received FDA 510(k) clearance on 1993-12-09. The listed applicant is Merchant House Scientific. The 510(k) number is K934961.

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

SPINPRO HDL PRECIPITATING REAGENT received FDA 510(k) clearance on 1993-12-09, under 510(k) number K934961.

Who is the listed applicant for SPINPRO 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 SPINPRO HDL PRECIPITATING REAGENT?

The FDA product code for SPINPRO 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K941744PBI PLUS 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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