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FDA 510(k)

BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL

K-Number: K920525 · 1992-08-05

ApplicantBiotrack, Inc.
Decision Date1992-08-05
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Biotrack, Inc.. It received FDA 510(k) clearance on 1992-08-05 under 510(k) number K920525. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL?

BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL is a medical device that received FDA 510(k) clearance on 1992-08-05. The listed applicant is Biotrack, Inc.. The 510(k) number is K920525.

When did BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL receive FDA 510(k) clearance?

BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL received FDA 510(k) clearance on 1992-08-05, under 510(k) number K920525.

Who is the listed applicant for BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL?

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. CONTROL?

The FDA product code for BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL is DIS.

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Other records listing Biotrack, 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.

K934062BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLSK934061BIOTRACK VALPROIC ACID TEST CARTRIDGEK915756BIOTRACK CARBAMAZEPINE TEST CARTRIDGEK915755BIOTRACK PHENYTOIN TEST CARTRIDGEK903924BIOTRACK THEOPHYLLINE QUALITY CONTROLSK900373BIOTRACK THEOPHYLLINE TEST CARTRIDGE

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Related Devices (Code: DIS)

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.

K161714Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis CorporationK092268RANDOX BARITURATES ASSAYRandox Laboratories, Ltd.K110515UCP DRUG SCREENING TEST CUPSUcp Biosciences, Inc.K070098QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SCPhamatech, Inc.K070009AT HOME DRUG TEST MODELS, 9308T AND 9308XPhamatech, Inc.K062165VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERSOrtho-Clinical Diagnostics

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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