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FDA 510(k)

VALPROIC ACID (FPIA) KIT

K-Number: K895569 · 1989-10-03

ApplicantTudor Laboratories, Inc.
Decision Date1989-10-03
Product CodeLEG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VALPROIC ACID (FPIA) KIT is the device name listed in this FDA 510(k) record. The listed applicant is Tudor Laboratories, Inc.. It received FDA 510(k) clearance on 1989-10-03 under 510(k) number K895569. 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 (FPIA) KIT?

VALPROIC ACID (FPIA) KIT is a medical device that received FDA 510(k) clearance on 1989-10-03. The listed applicant is Tudor Laboratories, Inc.. The 510(k) number is K895569.

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

VALPROIC ACID (FPIA) KIT received FDA 510(k) clearance on 1989-10-03, under 510(k) number K895569.

Who is the listed applicant for VALPROIC ACID (FPIA) KIT?

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

What is the FDA product code for VALPROIC ACID (FPIA) KIT?

The FDA product code for VALPROIC ACID (FPIA) KIT is LEG.

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Other records listing Tudor 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.

K921904THYROXINE (FPIA) KITK921903THYROXINE CALIBRATOR KITK913240DIGITOXIN (FPIA) KITK895572N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KITK895571N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KITK895567PRIMIDONE (FPIA) KIT

View all 9 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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