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FDA 510(k)

INNOFLUOR PHENYTOIN

K-Number: K841706 · 1984-05-22

ApplicantInnotron Diagnostics
Decision Date1984-05-22
Product CodeLGR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOFLUOR PHENYTOIN is the device name listed in this FDA 510(k) record. The listed applicant is Innotron Diagnostics. It received FDA 510(k) clearance on 1984-05-22 under 510(k) number K841706. 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 INNOFLUOR PHENYTOIN?

INNOFLUOR PHENYTOIN is a medical device that received FDA 510(k) clearance on 1984-05-22. The listed applicant is Innotron Diagnostics. The 510(k) number is K841706.

When did INNOFLUOR PHENYTOIN receive FDA 510(k) clearance?

INNOFLUOR PHENYTOIN received FDA 510(k) clearance on 1984-05-22, under 510(k) number K841706.

Who is the listed applicant for INNOFLUOR PHENYTOIN?

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

What is the FDA product code for INNOFLUOR PHENYTOIN?

The FDA product code for INNOFLUOR PHENYTOIN is LGR.

Related Clinical Trials

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.

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Other records listing Innotron Diagnostics 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.

K850629INNOFLUOR THEOPHYLLINEK844721INNOFLUOR PRIMIDONEK841865INNOFLOUR GENTAMICINK841866INNOFLOUR TOBRAMYCINK841707INNOFLUOR PHENOBARBITAL

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 LaboratoriesK946328TDX(R)/TDXFLX(R) PHENYTOIN IIAbbott LaboratoriesK943313PHENYTOIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K935375AXSYM PHENYTOIN ASSAYAbbott 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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