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FDA 510(k)

IMMUNOASSAY DRUGS OF ABUSE CONTROLS

K-Number: K952056 · 1995-06-01

ApplicantMedi-Tech, Inc.
Decision Date1995-06-01
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMUNOASSAY DRUGS OF ABUSE CONTROLS 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 1995-06-01 under 510(k) number K952056. 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 IMMUNOASSAY DRUGS OF ABUSE CONTROLS?

IMMUNOASSAY DRUGS OF ABUSE CONTROLS is a medical device that received FDA 510(k) clearance on 1995-06-01. The listed applicant is Medi-Tech, Inc.. The 510(k) number is K952056.

When did IMMUNOASSAY DRUGS OF ABUSE CONTROLS receive FDA 510(k) clearance?

IMMUNOASSAY DRUGS OF ABUSE CONTROLS received FDA 510(k) clearance on 1995-06-01, under 510(k) number K952056.

Who is the listed applicant for IMMUNOASSAY DRUGS OF ABUSE CONTROLS?

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 IMMUNOASSAY DRUGS OF ABUSE CONTROLS?

The FDA product code for IMMUNOASSAY DRUGS OF ABUSE CONTROLS 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 CATHETERK945289DOA - IMMUNOASSAY CUT-OFF CALIBRATORK942551THERAPEUTIC DRUG MONITORING CONTROL, ASSAYEDK943290BILIRUBIN PLUS/PEDIATRIC CONTROLSK922990HEMODIALYSIS BATH

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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