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FDA 510(k)

MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA

K-Number: K900706 · 1990-04-12

ApplicantInnotron of Oregon, Inc.
Decision Date1990-04-12
Product CodeLGS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA is the device name listed in this FDA 510(k) record. The listed applicant is Innotron of Oregon, Inc.. It received FDA 510(k) clearance on 1990-04-12 under 510(k) number K900706. 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 MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA?

MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA is a medical device that received FDA 510(k) clearance on 1990-04-12. The listed applicant is Innotron of Oregon, Inc.. The 510(k) number is K900706.

When did MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA receive FDA 510(k) clearance?

MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA received FDA 510(k) clearance on 1990-04-12, under 510(k) number K900706.

Who is the listed applicant for MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA?

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

What is the FDA product code for MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA?

The FDA product code for MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA is LGS.

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Other records listing Innotron of Oregon, 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.

K903101INNOFLUOR (TM) AMIKACIN CALIBRATOR SETK903100INNOFLUOR (TM) AMIKACIN REAGENT SETK900707MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATORK900708MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATORK900703MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATORK900705MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR

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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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