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FDA 510(k)

ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35

K-Number: K090358 · 2009-08-06

ApplicantAbbott Laboratories, Inc.
Decision Date2009-08-06
Product CodeLEG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories, Inc.. It received FDA 510(k) clearance on 2009-08-06 under 510(k) number K090358. 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 ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35?

ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 is a medical device that received FDA 510(k) clearance on 2009-08-06. The listed applicant is Abbott Laboratories, Inc.. The 510(k) number is K090358.

When did ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 receive FDA 510(k) clearance?

ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 received FDA 510(k) clearance on 2009-08-06, under 510(k) number K090358.

Who is the listed applicant for ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35?

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

What is the FDA product code for ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35?

The FDA product code for ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 is LEG.

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Other records listing Abbott Laboratories, Inc. 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.

K061193CREATININEK051213PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPSK040954FOX PLUS PTA CATHETERK040761AXSYM CYCLOSPORINEK023062GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT

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.

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.K030405QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075Seradyn

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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