Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BIOTRACK THEOPHYLLINE QUALITY CONTROLS

K-Number: K903924 · 1990-09-17

ApplicantBiotrack, Inc.
Decision Date1990-09-17
Product CodeLAW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIOTRACK THEOPHYLLINE QUALITY 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 1990-09-17 under 510(k) number K903924. The device is classified under product code LAW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTRACK THEOPHYLLINE QUALITY CONTROLS?

BIOTRACK THEOPHYLLINE QUALITY CONTROLS is a medical device that received FDA 510(k) clearance on 1990-09-17. The listed applicant is Biotrack, Inc.. The 510(k) number is K903924.

When did BIOTRACK THEOPHYLLINE QUALITY CONTROLS receive FDA 510(k) clearance?

BIOTRACK THEOPHYLLINE QUALITY CONTROLS received FDA 510(k) clearance on 1990-09-17, under 510(k) number K903924.

Who is the listed applicant for BIOTRACK THEOPHYLLINE QUALITY 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 THEOPHYLLINE QUALITY CONTROLS?

The FDA product code for BIOTRACK THEOPHYLLINE QUALITY CONTROLS is LAW.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 CARTRIDGEK900373BIOTRACK THEOPHYLLINE TEST CARTRIDGE

View all 16 devices →

Related Devices (Code: LAW)

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.

K920223CHEM CHEX THEOPHYLLINE CONTROLStreck Laboratories, Inc.K914251MODEL IRC PASSPORT NEBULIZERInvacare Corp.K871589THEOPHYLLINE FPIA CONTROLSSigma Chemical Co.

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.

↑