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FDA 510(k)

QMS THEOPHYLLINE CS

K-Number: K942991 · 1994-09-09

ApplicantSeradyn, Inc.
Decision Date1994-09-09
Product CodeLGS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QMS THEOPHYLLINE CS is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 1994-09-09 under 510(k) number K942991. The device is classified under product code LGS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QMS THEOPHYLLINE CS?

QMS THEOPHYLLINE CS is a medical device that received FDA 510(k) clearance on 1994-09-09. The listed applicant is Seradyn, Inc.. The 510(k) number is K942991.

When did QMS THEOPHYLLINE CS receive FDA 510(k) clearance?

QMS THEOPHYLLINE CS received FDA 510(k) clearance on 1994-09-09, under 510(k) number K942991.

Who is the listed applicant for QMS THEOPHYLLINE CS?

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 THEOPHYLLINE CS?

The FDA product code for QMS THEOPHYLLINE CS is LGS.

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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: LGS)

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.

K070810ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)Biokit, S.A.K955567INNOFLUOR THEOPHYLLINE ASSAY SYSTEMOxis Intl., Inc.K953016AXSYM THEOPHYLLINE IIAbbott LaboratoriesK951169CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAYCiba Corning Diagnostics Corp.K932127TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL IIAbbott LaboratoriesK922991ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINEAbbott 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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