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FDA 510(k)

INNOFLUOR PHENOBARBITAL

K-Number: K841707 · 1984-05-23

ApplicantInnotron Diagnostics
Decision Date1984-05-23
Product CodeLGQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOFLUOR PHENOBARBITAL is the device name listed in this FDA 510(k) record. The listed applicant is Innotron Diagnostics. It received FDA 510(k) clearance on 1984-05-23 under 510(k) number K841707. The device is classified under product code LGQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOFLUOR PHENOBARBITAL?

INNOFLUOR PHENOBARBITAL is a medical device that received FDA 510(k) clearance on 1984-05-23. The listed applicant is Innotron Diagnostics. The 510(k) number is K841707.

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

INNOFLUOR PHENOBARBITAL received FDA 510(k) clearance on 1984-05-23, under 510(k) number K841707.

Who is the listed applicant for INNOFLUOR PHENOBARBITAL?

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 PHENOBARBITAL?

The FDA product code for INNOFLUOR PHENOBARBITAL is LGQ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 TOBRAMYCINK841706INNOFLUOR PHENYTOIN

Related Devices (Code: LGQ)

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.

K972331INNOFLUOR GENTAMICIN ASSAY SYSTEMOxis Intl., Inc.K972330INNOFLUOR PHENOBARBITAL ASSAY SYSTEMOxis Intl., Inc.K940596AXSYM PHENOBARBITALAbbott LaboratoriesK936130COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORSRoche Diagnostic Systems, Inc.K900704MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRAInnotron of Oregon, Inc.K894525FPR PHENOBARBITAL KITColony Laboratories, 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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