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FDA 510(k)

INNOFLUOR THEOPHYLLINE

K-Number: K850629 · 1985-03-12

ApplicantInnotron Diagnostics
Decision Date1985-03-12
Product CodeLGS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOFLUOR THEOPHYLLINE is the device name listed in this FDA 510(k) record. The listed applicant is Innotron Diagnostics. It received FDA 510(k) clearance on 1985-03-12 under 510(k) number K850629. 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 INNOFLUOR THEOPHYLLINE?

INNOFLUOR THEOPHYLLINE is a medical device that received FDA 510(k) clearance on 1985-03-12. The listed applicant is Innotron Diagnostics. The 510(k) number is K850629.

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

INNOFLUOR THEOPHYLLINE received FDA 510(k) clearance on 1985-03-12, under 510(k) number K850629.

Who is the listed applicant for INNOFLUOR THEOPHYLLINE?

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 THEOPHYLLINE?

The FDA product code for INNOFLUOR THEOPHYLLINE is LGS.

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.

K844721INNOFLUOR PRIMIDONEK841865INNOFLOUR GENTAMICINK841866INNOFLOUR TOBRAMYCINK841707INNOFLUOR PHENOBARBITALK841706INNOFLUOR PHENYTOIN

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.K942991QMS THEOPHYLLINE CSSeradyn, Inc.K932127TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL IIAbbott 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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