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FDA 510(k)

DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS

K-Number: K060489 · 2006-07-21

ApplicantDade Behring, Inc.
Decision Date2006-07-21
Product CodeJOZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS 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 2006-07-21 under 510(k) number K060489. The device is classified under product code JOZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS?

DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS is a medical device that received FDA 510(k) clearance on 2006-07-21. The listed applicant is Dade Behring, Inc.. The 510(k) number is K060489.

When did DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS receive FDA 510(k) clearance?

DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS received FDA 510(k) clearance on 2006-07-21, under 510(k) number K060489.

Who is the listed applicant for DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS?

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 DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS?

The FDA product code for DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS is JOZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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