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FDA 510(k)

QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075

K-Number: K030405 · 2003-04-28

ApplicantSeradyn
Decision Date2003-04-28
Product CodeLEG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn. It received FDA 510(k) clearance on 2003-04-28 under 510(k) number K030405. 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 QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075?

QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 is a medical device that received FDA 510(k) clearance on 2003-04-28. The listed applicant is Seradyn. The 510(k) number is K030405.

When did QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 receive FDA 510(k) clearance?

QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 received FDA 510(k) clearance on 2003-04-28, under 510(k) number K030405.

Who is the listed applicant for QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075?

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

What is the FDA product code for QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075?

The FDA product code for QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 is LEG.

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Other records listing Seradyn 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.

K023058QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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