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FDA 510(k)

FPR CARBAMAZEPINE CALIBRATOR KIT

K-Number: K894520 · 1989-08-28

ApplicantColony Laboratories, Inc.
Decision Date1989-08-28
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

FPR CARBAMAZEPINE CALIBRATOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Colony Laboratories, Inc.. It received FDA 510(k) clearance on 1989-08-28 under 510(k) number K894520. 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 FPR CARBAMAZEPINE CALIBRATOR KIT?

FPR CARBAMAZEPINE CALIBRATOR KIT is a medical device that received FDA 510(k) clearance on 1989-08-28. The listed applicant is Colony Laboratories, Inc.. The 510(k) number is K894520.

When did FPR CARBAMAZEPINE CALIBRATOR KIT receive FDA 510(k) clearance?

FPR CARBAMAZEPINE CALIBRATOR KIT received FDA 510(k) clearance on 1989-08-28, under 510(k) number K894520.

Who is the listed applicant for FPR CARBAMAZEPINE CALIBRATOR KIT?

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

What is the FDA product code for FPR CARBAMAZEPINE CALIBRATOR KIT?

The FDA product code for FPR CARBAMAZEPINE CALIBRATOR KIT is DLJ.

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Other records listing Colony Laboratories, 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.

K894524FPR GENTAMICIN CALIBRATOR KITK894517FPR AMIKACIN KITK894523FPR GENTAMICIN KITK894518FPR AMIKACIN CALIBRATOR KITK894527FPR PHENYTOIN KITK894521FPR DIGOXIN KIT

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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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