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FDA 510(k)

DGTX FLEX REAGENT CARTRIDGE, MODEL DF36

K-Number: K990251 · 1999-03-31

ApplicantDade Behring, Inc.
Decision Date1999-03-31
Product CodeLFM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 1999-03-31 under 510(k) number K990251. 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 DGTX FLEX REAGENT CARTRIDGE, MODEL DF36?

DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 is a medical device that received FDA 510(k) clearance on 1999-03-31. The listed applicant is Dade Behring, Inc.. The 510(k) number is K990251.

When did DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 receive FDA 510(k) clearance?

DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 received FDA 510(k) clearance on 1999-03-31, under 510(k) number K990251.

Who is the listed applicant for DGTX FLEX REAGENT CARTRIDGE, MODEL DF36?

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

What is the FDA product code for DGTX FLEX REAGENT CARTRIDGE, MODEL DF36?

The FDA product code for DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 is LFM.

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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.K970546ACS DIGITOXINChiron Diagnostics Corp.K963158ABBOTT AXSYM DIGITOXIN (MODIFY)Abbott LaboratoriesK954420AXSYM DIGITOXINAbbott LaboratoriesK951631DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMSBayer Corp.

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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