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FDA 510(k)

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II

K-Number: K983747 · 1998-12-30

ApplicantBeckman Coulter, Inc.
Decision Date1998-12-30
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II 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 1998-12-30 under 510(k) number K983747. The device is classified under product code DKB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II?

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II is a medical device that received FDA 510(k) clearance on 1998-12-30. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K983747.

When did SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II receive FDA 510(k) clearance?

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II received FDA 510(k) clearance on 1998-12-30, under 510(k) number K983747.

Who is the listed applicant for SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II?

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 DAT LOW AND HIGH URINE CALIBRATORS II?

The FDA product code for SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II is DKB.

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Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: DKB)

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.

K120936ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORSMicrogenics CorporationK092266RANDOX METHAMPHETAMINE ASSAYRandox Laboratories, Ltd.K101752THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORSMicrogenics Corp.K090939ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190Roche DiagnosticsK090900ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771Siemens Healthcare DiagnosticsK062162DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)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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