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FDA 510(k)

SYNCHRON SYSTEMS AMPHETAMINE REAGENT

K-Number: K000606 · 2000-05-05

ApplicantBeckman Coulter, Inc.
Decision Date2000-05-05
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SYNCHRON SYSTEMS AMPHETAMINE 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 2000-05-05 under 510(k) number K000606. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRON SYSTEMS AMPHETAMINE REAGENT?

SYNCHRON SYSTEMS AMPHETAMINE REAGENT is a medical device that received FDA 510(k) clearance on 2000-05-05. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K000606.

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

SYNCHRON SYSTEMS AMPHETAMINE REAGENT received FDA 510(k) clearance on 2000-05-05, under 510(k) number K000606.

Who is the listed applicant for SYNCHRON SYSTEMS AMPHETAMINE 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 AMPHETAMINE REAGENT?

The FDA product code for SYNCHRON SYSTEMS AMPHETAMINE REAGENT is DKZ.

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Related Devices (Code: DKZ)

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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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