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FDA 510(k)

SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B

K-Number: K870564 · 1987-03-24

ApplicantAtlantic Antibodies
Decision Date1987-03-24
Product CodeMSJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B is the device name listed in this FDA 510(k) record. The listed applicant is Atlantic Antibodies. It received FDA 510(k) clearance on 1987-03-24 under 510(k) number K870564. 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 SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B?

SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B is a medical device that received FDA 510(k) clearance on 1987-03-24. The listed applicant is Atlantic Antibodies. The 510(k) number is K870564.

When did SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B receive FDA 510(k) clearance?

SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B received FDA 510(k) clearance on 1987-03-24, under 510(k) number K870564.

Who is the listed applicant for SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B?

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

What is the FDA product code for SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B?

The FDA product code for SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B is MSJ.

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Other records listing Atlantic Antibodies 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.

K892526SPQ TM TEST SYSTEM II FOR CRPK891154SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO BK890563SPQ(TM) ANTIBODY REAGENT SET II FOR TRFK890561SPQ(TM) ANTIBODY REAGENT SET II FOR IGMK890416SPQ(TM) ANTIBODY REAGENT SET II FOR IGGK890562SPQ(TM) ANTIBODY REAGENT SET II FOR HPT

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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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