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FDA 510(k)

TDX(R)/TDXFLX(R) PHENYTOIN II

K-Number: K946328 · 1995-03-28

ApplicantAbbott Laboratories
Decision Date1995-03-28
Product CodeLGR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TDX(R)/TDXFLX(R) PHENYTOIN II is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1995-03-28 under 510(k) number K946328. The device is classified under product code LGR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDX(R)/TDXFLX(R) PHENYTOIN II?

TDX(R)/TDXFLX(R) PHENYTOIN II is a medical device that received FDA 510(k) clearance on 1995-03-28. The listed applicant is Abbott Laboratories. The 510(k) number is K946328.

When did TDX(R)/TDXFLX(R) PHENYTOIN II receive FDA 510(k) clearance?

TDX(R)/TDXFLX(R) PHENYTOIN II received FDA 510(k) clearance on 1995-03-28, under 510(k) number K946328.

Who is the listed applicant for TDX(R)/TDXFLX(R) PHENYTOIN II?

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

What is the FDA product code for TDX(R)/TDXFLX(R) PHENYTOIN II?

The FDA product code for TDX(R)/TDXFLX(R) PHENYTOIN II is LGR.

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Related Devices (Code: LGR)

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.

K955873ACS PHENYTOIN ASSAYCiba Corning Diagnostics Corp.K955562INNOFLUOR PHENYTOIN ASSAY SYSTEMOxis Intl., Inc.K953840AXSYM PHENYTOIN IIAbbott LaboratoriesK943313PHENYTOIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K935375AXSYM PHENYTOIN ASSAYAbbott LaboratoriesK936131COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORSRoche Diagnostic Systems, Inc.

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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