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FDA 510(k)

KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)

K-Number: K942610 · 1994-10-20

ApplicantEastman Kodak Company
Decision Date1994-10-20
Product CodeLFM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) is the device name listed in this FDA 510(k) record. The listed applicant is Eastman Kodak Company. It received FDA 510(k) clearance on 1994-10-20 under 510(k) number K942610. 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 KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)?

KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) is a medical device that received FDA 510(k) clearance on 1994-10-20. The listed applicant is Eastman Kodak Company. The 510(k) number is K942610.

When did KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) receive FDA 510(k) clearance?

KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) received FDA 510(k) clearance on 1994-10-20, under 510(k) number K942610.

Who is the listed applicant for KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)?

The FDA 510(k) record lists Eastman Kodak Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)?

The FDA product code for KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) is LFM.

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Other records listing Eastman Kodak Company 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.

K060550KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386K060137KODAK ECLIPSE IMAGE PROCESSING SOFTWAREK060079KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEMK060055KODAK PACSK053347KODAK CARESTREAM PACSK051483KODAK DIRECTVIEW DR SYSTEM DETECTOR

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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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