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FDA 510(k)

VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM

K-Number: K964442 · 1996-12-18

ApplicantBayer Corp.
Decision Date1996-12-18
Product CodeLEG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1996-12-18 under 510(k) number K964442. 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 VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM?

VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM is a medical device that received FDA 510(k) clearance on 1996-12-18. The listed applicant is Bayer Corp.. The 510(k) number is K964442.

When did VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM receive FDA 510(k) clearance?

VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM received FDA 510(k) clearance on 1996-12-18, under 510(k) number K964442.

Who is the listed applicant for VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM?

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

What is the FDA product code for VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM?

The FDA product code for VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM is LEG.

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Other records listing Bayer Corp. 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.

K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

View all 96 devices →

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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