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FDA 510(k)

IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B

K-Number: K861882 · 1986-10-29

ApplicantOrion Corp.
Decision Date1986-10-29
Product CodeMSJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B is the device name listed in this FDA 510(k) record. The listed applicant is Orion Corp.. It received FDA 510(k) clearance on 1986-10-29 under 510(k) number K861882. 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 IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B?

IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B is a medical device that received FDA 510(k) clearance on 1986-10-29. The listed applicant is Orion Corp.. The 510(k) number is K861882.

When did IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B receive FDA 510(k) clearance?

IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B received FDA 510(k) clearance on 1986-10-29, under 510(k) number K861882.

Who is the listed applicant for IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B?

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

What is the FDA product code for IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B?

The FDA product code for IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B is MSJ.

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Other records listing Orion 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.

K912391RUBALEX, MODIFICATIONK901637RESUBMITTED MODIFIED RUBALEXK884650RESUBMITTED SCANORAK890199DENTOCULT SM-STRIP MUTANSK881506MAMEX DC MAG MG12K881505MAMEX DC MG11

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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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