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FDA 510(k)

CEDIA DIGITOXIN ASSAY

K-Number: K896021 · 1989-11-08

ApplicantMicrogenics Corp.
Decision Date1989-11-08
Product CodeLFM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA DIGITOXIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 1989-11-08 under 510(k) number K896021. 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 CEDIA DIGITOXIN ASSAY?

CEDIA DIGITOXIN ASSAY is a medical device that received FDA 510(k) clearance on 1989-11-08. The listed applicant is Microgenics Corp.. The 510(k) number is K896021.

When did CEDIA DIGITOXIN ASSAY receive FDA 510(k) clearance?

CEDIA DIGITOXIN ASSAY received FDA 510(k) clearance on 1989-11-08, under 510(k) number K896021.

Who is the listed applicant for CEDIA DIGITOXIN ASSAY?

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

What is the FDA product code for CEDIA DIGITOXIN ASSAY?

The FDA product code for CEDIA DIGITOXIN ASSAY is LFM.

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Other records listing Microgenics Corp. 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.

K122766THERMO SCIENTIFIC QMS EVEROLIMUS ASSAYK123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSK123271ABBOTT PHENOBARBITAL ASSAYK110616THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PROK101754THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAYK101746THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY

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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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