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FDA 510(k)

EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL

K-Number: K011947 · 2001-07-02

ApplicantSyva Co.
Decision Date2001-07-02
Product CodeLEG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 2001-07-02 under 510(k) number K011947. 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 EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL?

EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL is a medical device that received FDA 510(k) clearance on 2001-07-02. The listed applicant is Syva Co.. The 510(k) number is K011947.

When did EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL receive FDA 510(k) clearance?

EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL received FDA 510(k) clearance on 2001-07-02, under 510(k) number K011947.

Who is the listed applicant for EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL?

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

What is the FDA product code for EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL?

The FDA product code for EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL is LEG.

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Other records listing Syva Co. 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.

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULK012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229K011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409ULK993981SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL

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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

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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