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FDA 510(k)

MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT

K-Number: K872794 · 1987-09-23

ApplicantMedix Biotech, Inc.
Decision Date1987-09-23
Product CodeMSJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medix Biotech, Inc.. It received FDA 510(k) clearance on 1987-09-23 under 510(k) number K872794. 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 MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT?

MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT is a medical device that received FDA 510(k) clearance on 1987-09-23. The listed applicant is Medix Biotech, Inc.. The 510(k) number is K872794.

When did MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT receive FDA 510(k) clearance?

MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT received FDA 510(k) clearance on 1987-09-23, under 510(k) number K872794.

Who is the listed applicant for MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT?

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

What is the FDA product code for MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT?

The FDA product code for MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT is MSJ.

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Other records listing Medix Biotech, Inc. 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.

K952873MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)K952319CONTRAST & RAPID HCG URINE/SERUM TSTK932482MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010K932758MEDIX BIOTECH BESTEST HCG-URINE TEST KITK925436MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KITK924259MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100

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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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