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)

ROCHE ONLINE TDM VALPROIC ACID

K-Number: K032049 · 2003-08-22

ApplicantRoche Diagnostics Corp.
Decision Date2003-08-22
Product CodeLEG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ROCHE ONLINE TDM VALPROIC ACID is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2003-08-22 under 510(k) number K032049. 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 ROCHE ONLINE TDM VALPROIC ACID?

ROCHE ONLINE TDM VALPROIC ACID is a medical device that received FDA 510(k) clearance on 2003-08-22. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K032049.

When did ROCHE ONLINE TDM VALPROIC ACID receive FDA 510(k) clearance?

ROCHE ONLINE TDM VALPROIC ACID received FDA 510(k) clearance on 2003-08-22, under 510(k) number K032049.

Who is the listed applicant for ROCHE ONLINE TDM VALPROIC ACID?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROCHE ONLINE TDM VALPROIC ACID?

The FDA product code for ROCHE ONLINE TDM VALPROIC ACID is LEG.

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 Roche Diagnostics Corp. 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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

View all 263 devices →

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.K031870SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENTBeckman Coulter, Inc.K030405QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075Seradyn

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.

↑