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FDA 510(k)

RANDOX VALPROIC ACID

K-Number: K011649 · 2002-01-15

ApplicantRandox Laboratories, Ltd.
Decision Date2002-01-15
Product CodeLEG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RANDOX VALPROIC ACID is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2002-01-15 under 510(k) number K011649. 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 RANDOX VALPROIC ACID?

RANDOX VALPROIC ACID is a medical device that received FDA 510(k) clearance on 2002-01-15. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K011649.

When did RANDOX VALPROIC ACID receive FDA 510(k) clearance?

RANDOX VALPROIC ACID received FDA 510(k) clearance on 2002-01-15, under 510(k) number K011649.

Who is the listed applicant for RANDOX VALPROIC ACID?

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

What is the FDA product code for RANDOX VALPROIC ACID?

The FDA product code for RANDOX VALPROIC ACID is LEG.

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Other records listing Randox Laboratories, Ltd. 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.

K230890ISE ElectrodesK182042Randox Calcium (Ca)K162200Randox RX Daytona Plus Magnesium (MG)K152085Liquid CO2-2 (LCO2-2)K153435Direct HDL Cholesterol (HDL)K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

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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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