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FDA 510(k)

SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT

K-Number: K000494 · 2000-04-14

ApplicantBeckman Coulter, Inc.
Decision Date2000-04-14
Product CodeLDP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) 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 2000-04-14 under 510(k) number K000494. The device is classified under product code LDP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT?

SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT is a medical device that received FDA 510(k) clearance on 2000-04-14. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K000494.

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

SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT received FDA 510(k) clearance on 2000-04-14, under 510(k) number K000494.

Who is the listed applicant for SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) 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 ACETAMINOPHEN (ACTM) REAGENT?

The FDA product code for SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT is LDP.

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Related Devices (Code: LDP)

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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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