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FDA 510(k)

INNOFLUOR(TM) DIGITOXIN REAGENT SET

K-Number: K913187 · 1991-09-23

ApplicantIntl. Bioclinical, Inc.
Decision Date1991-09-23
Product CodeLFM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOFLUOR(TM) DIGITOXIN 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 1991-09-23 under 510(k) number K913187. The device is classified under product code LFM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOFLUOR(TM) DIGITOXIN REAGENT SET?

INNOFLUOR(TM) DIGITOXIN REAGENT SET is a medical device that received FDA 510(k) clearance on 1991-09-23. The listed applicant is Intl. Bioclinical, Inc.. The 510(k) number is K913187.

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

INNOFLUOR(TM) DIGITOXIN REAGENT SET received FDA 510(k) clearance on 1991-09-23, under 510(k) number K913187.

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

The FDA product code for INNOFLUOR(TM) DIGITOXIN REAGENT SET is LFM.

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.

K913186INNOFLUOR(TM) DIGITOXIN CALIBRATOR SETK911688INNOFLUOR(TM) VALPROIC ACID REAGENT SETK911466INNOFLUOR VALPROIC ACID CALIBRATOR SETK883533ABC FP ANALYZERK864156PROGESTERONE SYSTEM BY EIA

Related Devices (Code: LFM)

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.

K062024DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGEDade Behring, Inc.K012112RANDOX DIGITOXINRandox Laboratories, Ltd.K990251DGTX FLEX REAGENT CARTRIDGE, MODEL DF36Dade Behring, Inc.K970546ACS DIGITOXINChiron Diagnostics Corp.K963158ABBOTT AXSYM DIGITOXIN (MODIFY)Abbott LaboratoriesK954420AXSYM DIGITOXINAbbott Laboratories

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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