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FDA 510(k)

MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA

K-Number: K900702 · 1990-04-12

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

Device Summary

MODIFIED ACCUFLUOR CARBAMAZEPINE 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 K900702. The device is classified under product code LGI. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA?

MODIFIED ACCUFLUOR CARBAMAZEPINE 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 K900702.

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

MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA received FDA 510(k) clearance on 1990-04-12, under 510(k) number K900702.

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

The FDA product code for MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA is LGI.

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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 & CALIBRATORK900706MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRAK900703MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR

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Related Devices (Code: LGI)

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.

K944063FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINESigma Diagnostics, Inc.K940682AXSYM(TM) QUINIDINEAbbott 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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