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FDA 510(k)

APO A-1 CHEMILUMINESCENCE ASSAY

K-Number: K931777 · 1993-08-16

ApplicantNichols Institute
Decision Date1993-08-16
Product CodeMSJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

APO A-1 CHEMILUMINESCENCE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute. It received FDA 510(k) clearance on 1993-08-16 under 510(k) number K931777. 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 APO A-1 CHEMILUMINESCENCE ASSAY?

APO A-1 CHEMILUMINESCENCE ASSAY is a medical device that received FDA 510(k) clearance on 1993-08-16. The listed applicant is Nichols Institute. The 510(k) number is K931777.

When did APO A-1 CHEMILUMINESCENCE ASSAY receive FDA 510(k) clearance?

APO A-1 CHEMILUMINESCENCE ASSAY received FDA 510(k) clearance on 1993-08-16, under 510(k) number K931777.

Who is the listed applicant for APO A-1 CHEMILUMINESCENCE ASSAY?

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

What is the FDA product code for APO A-1 CHEMILUMINESCENCE ASSAY?

The FDA product code for APO A-1 CHEMILUMINESCENCE ASSAY is MSJ.

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Other records listing Nichols Institute 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.

K952559ERYTHROPOIETIN IMMUNOASSAY KITK952505INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)K946247IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3K950524NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAYK932650ERYTHROPOIETIN IMMUNOASSAY KITK931600CHEMILUMINESCENCE FREE T3 IMMUNOASSAY

View all 15 devices →

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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