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FDA 510(k)

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1

K-Number: K983709 · 1998-10-28

ApplicantBeckman Coulter, Inc.
Decision Date1998-10-28
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 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 1998-10-28 under 510(k) number K983709. The device is classified under product code DIF. 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 CONTROLS 1?

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 is a medical device that received FDA 510(k) clearance on 1998-10-28. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K983709.

When did SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 receive FDA 510(k) clearance?

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 received FDA 510(k) clearance on 1998-10-28, under 510(k) number K983709.

Who is the listed applicant for SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1?

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 CONTROLS 1?

The FDA product code for SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 is DIF.

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Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: DIF)

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.

K153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm seriesBiochemical Diagnostics, Inc.K132688SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZBiochemical Diagnostics, Inc.K132174MULTICHEM WBTTechno-Path Manufacturing , Ltd.K121122DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROLBiochemical Diagnostic, Inc.K121143LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)Bio-Rad LaboratoriesK120504LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAKBio-Rad Laboratories, 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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