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FDA 510(k)

SYNCHRON SYSTEMS AMMONIA REAGENT

K-Number: K003196 · 2000-12-22

ApplicantBeckman Coulter, Inc.
Decision Date2000-12-22
Product CodeJIF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNCHRON SYSTEMS AMMONIA REAGENT 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 2000-12-22 under 510(k) number K003196. The device is classified under product code JIF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRON SYSTEMS AMMONIA REAGENT?

SYNCHRON SYSTEMS AMMONIA REAGENT is a medical device that received FDA 510(k) clearance on 2000-12-22. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K003196.

When did SYNCHRON SYSTEMS AMMONIA REAGENT receive FDA 510(k) clearance?

SYNCHRON SYSTEMS AMMONIA REAGENT received FDA 510(k) clearance on 2000-12-22, under 510(k) number K003196.

Who is the listed applicant for SYNCHRON SYSTEMS AMMONIA REAGENT?

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 AMMONIA REAGENT?

The FDA product code for SYNCHRON SYSTEMS AMMONIA REAGENT is JIF.

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Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: JIF)

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.

K183517Ammonia IIRoche Diagnostics Operations (Rdo)K123677DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)Siemens Healthcare DiagnosticsK123320DIMENSION AMMONIA FLEX REAGENT CARTRIDGESiemens Healthcare DiagnosticsK062316DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGEDade Behring, Inc.K051114SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYSentinel Ch. SrlK033921AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10Diagnostic Chemicals , Ltd.

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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