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FDA 510(k)

SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT

K-Number: K051307 · 2005-06-13

ApplicantBeckman Coulter, Inc.
Decision Date2005-06-13
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) 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 2005-06-13 under 510(k) number K051307. 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 SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT?

SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT is a medical device that received FDA 510(k) clearance on 2005-06-13. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K051307.

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

SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT received FDA 510(k) clearance on 2005-06-13, under 510(k) number K051307.

Who is the listed applicant for SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) 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 BEBZODIAZAPINE (EBNZ) REAGENT?

The FDA product code for SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) 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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