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FDA 510(k)

INNOFLUOR VALPROIC ACID CALIBRATOR SET

K-Number: K911466 · 1991-05-23

ApplicantIntl. Bioclinical, Inc.
Decision Date1991-05-23
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOFLUOR VALPROIC ACID CALIBRATOR 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 1991-05-23 under 510(k) number K911466. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOFLUOR VALPROIC ACID CALIBRATOR SET?

INNOFLUOR VALPROIC ACID CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 1991-05-23. The listed applicant is Intl. Bioclinical, Inc.. The 510(k) number is K911466.

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

INNOFLUOR VALPROIC ACID CALIBRATOR SET received FDA 510(k) clearance on 1991-05-23, under 510(k) number K911466.

Who is the listed applicant for INNOFLUOR VALPROIC ACID CALIBRATOR 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 VALPROIC ACID CALIBRATOR SET?

The FDA product code for INNOFLUOR VALPROIC ACID CALIBRATOR SET is DLJ.

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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 SETK911688INNOFLUOR(TM) VALPROIC ACID REAGENT SETK883533ABC FP ANALYZERK864156PROGESTERONE SYSTEM BY EIA

Related Devices (Code: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)Dade Behring, 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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