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FDA 510(k)

MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR

K-Number: K900708 · 1990-04-19

ApplicantInnotron of Oregon, Inc.
Decision Date1990-04-19
Product CodeLEH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR 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 1990-04-19 under 510(k) number K900708. The device is classified under product code LEH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR?

MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR is a medical device that received FDA 510(k) clearance on 1990-04-19. The listed applicant is Innotron of Oregon, Inc.. The 510(k) number is K900708.

When did MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR receive FDA 510(k) clearance?

MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR received FDA 510(k) clearance on 1990-04-19, under 510(k) number K900708.

Who is the listed applicant for MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR?

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 VANCOMYCIN REAGENT & CALIBRATOR?

The FDA product code for MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR is LEH.

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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 & CALIBRATORK900706MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRAK900703MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATORK900705MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR

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Related Devices (Code: LEH)

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.

K222439Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc.K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)Siemens Healthcare Diagnostics, Inc.K152245ONLINE TDM Vancomycin Gen.3Roche Diagnostics Operations (Rdo)K123947ARCHITECT IVANCOMYCINBiokit, S.A.K072036ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01Biokit, S.A.K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINDiagnostic Products Corp.

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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