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FDA 510(k)

BIOTRACK PHENYTOIN TEST CARTRIDGE

K-Number: K915755 · 1992-07-23

ApplicantBiotrack, Inc.
Decision Date1992-07-23
Product CodeDIP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIOTRACK PHENYTOIN 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 1992-07-23 under 510(k) number K915755. The device is classified under product code DIP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTRACK PHENYTOIN TEST CARTRIDGE?

BIOTRACK PHENYTOIN TEST CARTRIDGE is a medical device that received FDA 510(k) clearance on 1992-07-23. The listed applicant is Biotrack, Inc.. The 510(k) number is K915755.

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

BIOTRACK PHENYTOIN TEST CARTRIDGE received FDA 510(k) clearance on 1992-07-23, under 510(k) number K915755.

Who is the listed applicant for BIOTRACK PHENYTOIN 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 PHENYTOIN TEST CARTRIDGE?

The FDA product code for BIOTRACK PHENYTOIN TEST CARTRIDGE is DIP.

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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 CARTRIDGEK920525BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROLK915756BIOTRACK CARBAMAZEPINE TEST CARTRIDGEK903924BIOTRACK THEOPHYLLINE QUALITY CONTROLSK900373BIOTRACK THEOPHYLLINE TEST CARTRIDGE

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Related Devices (Code: DIP)

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.

K080696ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01Abbott LaboratoriesK063145PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLSThermo Electron OYK030428ROCHE ONLINE TDM PHENYTOINRoche Diagnostics Corp.K011393RANDOX PHENYTOINRandox Laboratories, Ltd.K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229Syva Co.K000006IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6Diagnostic Products Corp.

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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