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FDA 510(k)

BIOTRACK THEOPHYLLINE TEST CARTRIDGE

K-Number: K900373 · 1990-05-30

ApplicantBiotrack, Inc.
Decision Date1990-05-30
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIOTRACK THEOPHYLLINE 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 1990-05-30 under 510(k) number K900373. The device is classified under product code KLS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTRACK THEOPHYLLINE TEST CARTRIDGE?

BIOTRACK THEOPHYLLINE TEST CARTRIDGE is a medical device that received FDA 510(k) clearance on 1990-05-30. The listed applicant is Biotrack, Inc.. The 510(k) number is K900373.

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

BIOTRACK THEOPHYLLINE TEST CARTRIDGE received FDA 510(k) clearance on 1990-05-30, under 510(k) number K900373.

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

The FDA product code for BIOTRACK THEOPHYLLINE TEST CARTRIDGE is KLS.

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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. CONTROLK915755BIOTRACK PHENYTOIN TEST CARTRIDGEK915756BIOTRACK CARBAMAZEPINE TEST CARTRIDGEK903924BIOTRACK THEOPHYLLINE QUALITY CONTROLS

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Related Devices (Code: KLS)

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.

K042520VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K042407EMIT CAFFEINE ASSAYDade Behring, Inc.K020740ROCHE ONLINE THEOPHYLLINERoche Diagnostics Corp.K011771RANDOX THEOPHYLLINERandox Laboratories, Ltd.K013272ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYBayer Corp.K011166MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229Syva Co., Dade Behring, 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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