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FDA 510(k)

SYNCHRON SYSTEMS DRUG CALIBRATOR 2

K-Number: K993473 · 1999-11-26

ApplicantBeckman Coulter, Inc.
Decision Date1999-11-26
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SYNCHRON SYSTEMS DRUG CALIBRATOR 2 is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 1999-11-26 under 510(k) number K993473. 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 SYNCHRON SYSTEMS DRUG CALIBRATOR 2?

SYNCHRON SYSTEMS DRUG CALIBRATOR 2 is a medical device that received FDA 510(k) clearance on 1999-11-26. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K993473.

When did SYNCHRON SYSTEMS DRUG CALIBRATOR 2 receive FDA 510(k) clearance?

SYNCHRON SYSTEMS DRUG CALIBRATOR 2 received FDA 510(k) clearance on 1999-11-26, under 510(k) number K993473.

Who is the listed applicant for SYNCHRON SYSTEMS DRUG CALIBRATOR 2?

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

What is the FDA product code for SYNCHRON SYSTEMS DRUG CALIBRATOR 2?

The FDA product code for SYNCHRON SYSTEMS DRUG CALIBRATOR 2 is DLJ.

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Other records listing Beckman Coulter, Inc. as applicant

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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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