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FDA 510(k)

QMS - DIGOXIN

K-Number: K913562 · 1991-08-30

ApplicantSeradyn, Inc.
Decision Date1991-08-30
Product CodeLCS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QMS - DIGOXIN is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 1991-08-30 under 510(k) number K913562. The device is classified under product code LCS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QMS - DIGOXIN?

QMS - DIGOXIN is a medical device that received FDA 510(k) clearance on 1991-08-30. The listed applicant is Seradyn, Inc.. The 510(k) number is K913562.

When did QMS - DIGOXIN receive FDA 510(k) clearance?

QMS - DIGOXIN received FDA 510(k) clearance on 1991-08-30, under 510(k) number K913562.

Who is the listed applicant for QMS - DIGOXIN?

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

What is the FDA product code for QMS - DIGOXIN?

The FDA product code for QMS - DIGOXIN is LCS.

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Other records listing Seradyn, 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.

K070645SERADYN QMS TOPIRAMATEK062966QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLSK062204ARCHITECT CORTISOL ASSAYK060998QMS TOBRAMYCINK060709MULTIGENT GENTAMICINK052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORS

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Related Devices (Code: LCS)

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.

K922353DIGOXIN COATED TUBE RIAMonobindK895828INNOFLUOR DIGOXIN REAGENT SETInnotron of Oregon, Inc.K884707FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KITCyberfluor, Inc.K874748IMMPULSE DIGOXIN ASSAY REAGENTSSclavo, Inc.K864802DART DIGOXIN ASSAYCoulter Electronics, Inc.K820154TDX DIGOXINAbbott 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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