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FDA 510(k)

EMIT 2000 DIGOXIN ASSAY/CALIBRATORS

K-Number: K942619 · 1994-09-20

ApplicantSyva Co.
Decision Date1994-09-20
Product CodeLFM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT 2000 DIGOXIN ASSAY/CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1994-09-20 under 510(k) number K942619. 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 EMIT 2000 DIGOXIN ASSAY/CALIBRATORS?

EMIT 2000 DIGOXIN ASSAY/CALIBRATORS is a medical device that received FDA 510(k) clearance on 1994-09-20. The listed applicant is Syva Co.. The 510(k) number is K942619.

When did EMIT 2000 DIGOXIN ASSAY/CALIBRATORS receive FDA 510(k) clearance?

EMIT 2000 DIGOXIN ASSAY/CALIBRATORS received FDA 510(k) clearance on 1994-09-20, under 510(k) number K942619.

Who is the listed applicant for EMIT 2000 DIGOXIN ASSAY/CALIBRATORS?

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

What is the FDA product code for EMIT 2000 DIGOXIN ASSAY/CALIBRATORS?

The FDA product code for EMIT 2000 DIGOXIN ASSAY/CALIBRATORS is LFM.

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Other records listing Syva Co. 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.

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULK012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULK011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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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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