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FDA 510(k)

SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT

K-Number: K984152 · 1999-01-29

ApplicantBeckman Coulter, Inc.
Decision Date1999-01-29
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) 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 1999-01-29 under 510(k) number K984152. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT?

SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT is a medical device that received FDA 510(k) clearance on 1999-01-29. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K984152.

When did SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT receive FDA 510(k) clearance?

SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT received FDA 510(k) clearance on 1999-01-29, under 510(k) number K984152.

Who is the listed applicant for SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) 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 OPIATES 2000 NG (OP2) REAGENT?

The FDA product code for SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT is DJG.

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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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