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FDA 510(k)

INNOFLUOR CARBAMAZEPINE CALIBRATOR SET

K-Number: K893506 · 1989-08-15

ApplicantInnotron of Oregon, Inc.
Decision Date1989-08-15
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INNOFLUOR CARBAMAZEPINE CALIBRATOR SET 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 1989-08-15 under 510(k) number K893506. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOFLUOR CARBAMAZEPINE CALIBRATOR SET?

INNOFLUOR CARBAMAZEPINE CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is Innotron of Oregon, Inc.. The 510(k) number is K893506.

When did INNOFLUOR CARBAMAZEPINE CALIBRATOR SET receive FDA 510(k) clearance?

INNOFLUOR CARBAMAZEPINE CALIBRATOR SET received FDA 510(k) clearance on 1989-08-15, under 510(k) number K893506.

Who is the listed applicant for INNOFLUOR CARBAMAZEPINE CALIBRATOR SET?

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 INNOFLUOR CARBAMAZEPINE CALIBRATOR SET?

The FDA product code for INNOFLUOR CARBAMAZEPINE CALIBRATOR SET is DLJ.

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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: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)Dade Behring, 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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