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FDA 510(k)

QMS TM- PHENYTOIN

K-Number: K904815 · 1990-11-06

ApplicantSeradyn, Inc.
Decision Date1990-11-06
Product CodeDIP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QMS TM- PHENYTOIN is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 1990-11-06 under 510(k) number K904815. The device is classified under product code DIP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QMS TM- PHENYTOIN?

QMS TM- PHENYTOIN is a medical device that received FDA 510(k) clearance on 1990-11-06. The listed applicant is Seradyn, Inc.. The 510(k) number is K904815.

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

QMS TM- PHENYTOIN received FDA 510(k) clearance on 1990-11-06, under 510(k) number K904815.

Who is the listed applicant for QMS TM- PHENYTOIN?

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 TM- PHENYTOIN?

The FDA product code for QMS TM- PHENYTOIN is DIP.

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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: DIP)

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.

K080696ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01Abbott LaboratoriesK063145PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLSThermo Electron OYK030428ROCHE ONLINE TDM PHENYTOINRoche Diagnostics Corp.K011393RANDOX PHENYTOINRandox Laboratories, Ltd.K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229Syva Co.K000006IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6Diagnostic Products Corp.

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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