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FDA 510(k)

ADVIA IMS VALPROIC ACID METHOD

K-Number: K042807 · 2005-02-08

ApplicantBayer Healthcare, LLC
Decision Date2005-02-08
Product CodeLEG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ADVIA IMS VALPROIC ACID METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare, LLC. It received FDA 510(k) clearance on 2005-02-08 under 510(k) number K042807. 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 ADVIA IMS VALPROIC ACID METHOD?

ADVIA IMS VALPROIC ACID METHOD is a medical device that received FDA 510(k) clearance on 2005-02-08. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K042807.

When did ADVIA IMS VALPROIC ACID METHOD receive FDA 510(k) clearance?

ADVIA IMS VALPROIC ACID METHOD received FDA 510(k) clearance on 2005-02-08, under 510(k) number K042807.

Who is the listed applicant for ADVIA IMS VALPROIC ACID METHOD?

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

What is the FDA product code for ADVIA IMS VALPROIC ACID METHOD?

The FDA product code for ADVIA IMS VALPROIC ACID METHOD is LEG.

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K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)K121190CONTOUR NEXT BLOOD GLUCOSE METERK110587CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)K093930DIDGET WORLD REPORTSK090628DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080K090413A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC

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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.K042476VITROS 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.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.

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