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FDA 510(k)

MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT

K-Number: K023048 · 2002-11-07

ApplicantBeckman Coulter, Inc.
Decision Date2002-11-07
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE 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 2002-11-07 under 510(k) number K023048. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT?

MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT is a medical device that received FDA 510(k) clearance on 2002-11-07. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K023048.

When did MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT receive FDA 510(k) clearance?

MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT received FDA 510(k) clearance on 2002-11-07, under 510(k) number K023048.

Who is the listed applicant for MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE 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 MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT?

The FDA product code for MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT is JXM.

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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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