FDA 510(k)

QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL

K-Number: K853933 · 1985-10-04

Decision Date1985-10-04

Product CodeDIF

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Corp.. It received FDA 510(k) clearance on 1985-10-04 under 510(k) number K853933. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL?

QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is Quantimetrix Corp.. The 510(k) number is K853933.

When did QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL receive FDA 510(k) clearance?

QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL received FDA 510(k) clearance on 1985-10-04, under 510(k) number K853933.

Who is the listed applicant for QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL?

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

What is the FDA product code for QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL?

The FDA product code for QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL is DIF.

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Other records listing Quantimetrix Corp. as applicant

K113177COMPLETE D 25-OH VITAMIN D CONTROL K103744DROPPER A1C DIABETES CONTROL K062942QUANTIMETRIX NICOSURE COTININE URINE CONTROL K062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER K060417MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL K032791GLYCOHEMOSURE HBA1C CONTROL

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Related Devices (Code: DIF)

K153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm seriesBiochemical Diagnostics, Inc.K132688SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZBiochemical Diagnostics, Inc.K132174MULTICHEM WBTTechno-Path Manufacturing , Ltd.K121122DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROLBiochemical Diagnostic, Inc.K121143LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)Bio-Rad Laboratories K120504LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAKBio-Rad Laboratories, 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.