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FDA 510(k)

BIOTRACK VALPROIC ACID TEST CARTRIDGE

K-Number: K934061 · 1993-12-29

ApplicantBiotrack, Inc.
Decision Date1993-12-29
Product CodeLEG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIOTRACK VALPROIC ACID TEST CARTRIDGE 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 K934061. The device is classified under product code LEG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTRACK VALPROIC ACID TEST CARTRIDGE?

BIOTRACK VALPROIC ACID TEST CARTRIDGE 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 K934061.

When did BIOTRACK VALPROIC ACID TEST CARTRIDGE receive FDA 510(k) clearance?

BIOTRACK VALPROIC ACID TEST CARTRIDGE received FDA 510(k) clearance on 1993-12-29, under 510(k) number K934061.

Who is the listed applicant for BIOTRACK VALPROIC ACID TEST CARTRIDGE?

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 VALPROIC ACID TEST CARTRIDGE?

The FDA product code for BIOTRACK VALPROIC ACID TEST CARTRIDGE is LEG.

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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 CONTROLSK920525BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROLK915756BIOTRACK CARBAMAZEPINE TEST CARTRIDGEK915755BIOTRACK PHENYTOIN TEST CARTRIDGEK903924BIOTRACK THEOPHYLLINE QUALITY CONTROLSK900373BIOTRACK THEOPHYLLINE TEST CARTRIDGE

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Related Devices (Code: LEG)

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.

K090358ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35Abbott Laboratories, Inc.K060690ONLINE VALPROIC ACIDRoche Diagnostics Corp.K042807ADVIA IMS VALPROIC ACID METHODBayer Healthcare, LLCK042476VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOSOrtho-Clinical Diagnostics, Inc.K032049ROCHE ONLINE TDM VALPROIC ACIDRoche Diagnostics Corp.K031870SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENTBeckman Coulter, 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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