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FDA 510(k)

DIGITOXIN (FPIA) KIT

K-Number: K913240 · 1991-09-06

ApplicantTudor Laboratories, Inc.
Decision Date1991-09-06
Product CodeLFM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIGITOXIN (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 1991-09-06 under 510(k) number K913240. 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 DIGITOXIN (FPIA) KIT?

DIGITOXIN (FPIA) KIT is a medical device that received FDA 510(k) clearance on 1991-09-06. The listed applicant is Tudor Laboratories, Inc.. The 510(k) number is K913240.

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

DIGITOXIN (FPIA) KIT received FDA 510(k) clearance on 1991-09-06, under 510(k) number K913240.

Who is the listed applicant for DIGITOXIN (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 DIGITOXIN (FPIA) KIT?

The FDA product code for DIGITOXIN (FPIA) KIT is LFM.

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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 KITK895572N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KITK895571N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KITK895567PRIMIDONE (FPIA) KITK895569VALPROIC ACID (FPIA) KIT

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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

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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