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FDA 510(k)

APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM

K-Number: K882620 · 1988-07-08

ApplicantTechnicon Instruments Corp.
Decision Date1988-07-08
Product CodeMSJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1988-07-08 under 510(k) number K882620. The device is classified under product code MSJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM?

APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K882620.

When did APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM receive FDA 510(k) clearance?

APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM received FDA 510(k) clearance on 1988-07-08, under 510(k) number K882620.

Who is the listed applicant for APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM?

The FDA 510(k) record lists Technicon Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM?

The FDA product code for APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM is MSJ.

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Other records listing Technicon Instruments Corp. 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.

K914888TECHNICON CHEM 1(TM) SYST (GEN2 SYST)K914511TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOLK914025TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)K912616TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTESK912413CHEM-LINK DATA BASE MANAGERK903824DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY

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Related Devices (Code: MSJ)

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.

K072977DIAZYME APOLIPOPROTEIN A-1 ASSAYGeneral AtomicsK073488DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXXDiazyme LaboratoriesK061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORSPointe Scientific, Inc.,K063608DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGHDade Behring, Inc.K9926628 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMBayer Corp.K970314SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTSBeckman Instruments, 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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