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FDA 510(k)

APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN

K-Number: K853174 · 1985-08-22

ApplicantPhotec Diagnostics, Inc.
Decision Date1985-08-22
Product CodeMSJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN is the device name listed in this FDA 510(k) record. The listed applicant is Photec Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-08-22 under 510(k) number K853174. 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-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN?

APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN is a medical device that received FDA 510(k) clearance on 1985-08-22. The listed applicant is Photec Diagnostics, Inc.. The 510(k) number is K853174.

When did APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN receive FDA 510(k) clearance?

APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN received FDA 510(k) clearance on 1985-08-22, under 510(k) number K853174.

Who is the listed applicant for APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN?

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

What is the FDA product code for APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN?

The FDA product code for APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN is MSJ.

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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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