FDA 510(k)

BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS

K-Number: K934062 · 1993-12-29

Decision Date1993-12-29

Product CodeDIF

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Biotrack, Inc.. It received FDA 510(k) clearance on 1993-12-29 under 510(k) number K934062. 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 BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS?

BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS is a medical device that received FDA 510(k) clearance on 1993-12-29. The listed applicant is Biotrack, Inc.. The 510(k) number is K934062.

When did BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS receive FDA 510(k) clearance?

BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS received FDA 510(k) clearance on 1993-12-29, under 510(k) number K934062.

Who is the listed applicant for BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS?

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

What is the FDA product code for BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS?

The FDA product code for BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS is DIF.

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Other records listing Biotrack, Inc. as applicant

K934061BIOTRACK VALPROIC ACID TEST CARTRIDGE K920525BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL K915756BIOTRACK CARBAMAZEPINE TEST CARTRIDGE K915755BIOTRACK PHENYTOIN TEST CARTRIDGE K903924BIOTRACK THEOPHYLLINE QUALITY CONTROLS K900373BIOTRACK THEOPHYLLINE TEST CARTRIDGE

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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

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