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FDA 510(k)

DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A

K-Number: K071767 · 2007-08-04

ApplicantDade Behring, Inc.
Decision Date2007-08-04
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2007-08-04 under 510(k) number K071767. The device is classified under product code NBC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A?

DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A is a medical device that received FDA 510(k) clearance on 2007-08-04. The listed applicant is Dade Behring, Inc.. The 510(k) number is K071767.

When did DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A receive FDA 510(k) clearance?

DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A received FDA 510(k) clearance on 2007-08-04, under 510(k) number K071767.

Who is the listed applicant for DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A?

The FDA 510(k) record lists Dade Behring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A?

The FDA product code for DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A is NBC.

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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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