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FDA 510(k)

THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED

K-Number: K942552 · 1994-09-09

ApplicantMedi-Tech, Inc.
Decision Date1994-09-09
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Tech, Inc.. It received FDA 510(k) clearance on 1994-09-09 under 510(k) number K942552. 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 THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED?

THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED is a medical device that received FDA 510(k) clearance on 1994-09-09. The listed applicant is Medi-Tech, Inc.. The 510(k) number is K942552.

When did THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED receive FDA 510(k) clearance?

THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED received FDA 510(k) clearance on 1994-09-09, under 510(k) number K942552.

Who is the listed applicant for THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED?

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

What is the FDA product code for THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED?

The FDA product code for THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED is DIF.

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Other records listing Medi-Tech, Inc. as applicant

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K954457MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETERK952345MEDI-TECH PLATFORM GUIDE CATHETERK952056IMMUNOASSAY DRUGS OF ABUSE CONTROLSK945289DOA - IMMUNOASSAY CUT-OFF CALIBRATORK942551THERAPEUTIC DRUG MONITORING CONTROL, ASSAYEDK943290BILIRUBIN PLUS/PEDIATRIC CONTROLS

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Related Devices (Code: DIF)

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.

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 LaboratoriesK120504LIQUICHEK 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.

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