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FDA 510(k)

INNOFLUOR(TM) VALPROIC ACID REAGENT SET

K-Number: K911688 · 1991-07-05

ApplicantIntl. Bioclinical, Inc.
Decision Date1991-07-05
Product CodeLEG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOFLUOR(TM) VALPROIC ACID REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Bioclinical, Inc.. It received FDA 510(k) clearance on 1991-07-05 under 510(k) number K911688. 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 INNOFLUOR(TM) VALPROIC ACID REAGENT SET?

INNOFLUOR(TM) VALPROIC ACID REAGENT SET is a medical device that received FDA 510(k) clearance on 1991-07-05. The listed applicant is Intl. Bioclinical, Inc.. The 510(k) number is K911688.

When did INNOFLUOR(TM) VALPROIC ACID REAGENT SET receive FDA 510(k) clearance?

INNOFLUOR(TM) VALPROIC ACID REAGENT SET received FDA 510(k) clearance on 1991-07-05, under 510(k) number K911688.

Who is the listed applicant for INNOFLUOR(TM) VALPROIC ACID REAGENT SET?

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

What is the FDA product code for INNOFLUOR(TM) VALPROIC ACID REAGENT SET?

The FDA product code for INNOFLUOR(TM) VALPROIC ACID REAGENT SET is LEG.

Related Clinical Trials

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.

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Other records listing Intl. Bioclinical, 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.

K913187INNOFLUOR(TM) DIGITOXIN REAGENT SETK913186INNOFLUOR(TM) DIGITOXIN CALIBRATOR SETK911466INNOFLUOR VALPROIC ACID CALIBRATOR SETK883533ABC FP ANALYZERK864156PROGESTERONE SYSTEM BY EIA

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

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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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