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FDA 510(k)

NICHOLS APO B CHEMILUMINESCENCE ASSAY

K-Number: K925702 · 1992-12-23

ApplicantNichols Institute Diagnostics
Decision Date1992-12-23
Product CodeMSJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NICHOLS APO B CHEMILUMINESCENCE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1992-12-23 under 510(k) number K925702. 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 NICHOLS APO B CHEMILUMINESCENCE ASSAY?

NICHOLS APO B CHEMILUMINESCENCE ASSAY is a medical device that received FDA 510(k) clearance on 1992-12-23. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K925702.

When did NICHOLS APO B CHEMILUMINESCENCE ASSAY receive FDA 510(k) clearance?

NICHOLS APO B CHEMILUMINESCENCE ASSAY received FDA 510(k) clearance on 1992-12-23, under 510(k) number K925702.

Who is the listed applicant for NICHOLS APO B CHEMILUMINESCENCE ASSAY?

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

What is the FDA product code for NICHOLS APO B CHEMILUMINESCENCE ASSAY?

The FDA product code for NICHOLS APO B CHEMILUMINESCENCE ASSAY is MSJ.

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Other records listing Nichols Institute Diagnostics 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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

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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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