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FDA 510(k)

IMMEDIA PROTHROMBIN TIME SYSTEM

K-Number: K050243 · 2005-06-06

ApplicantFarallon Medial, Inc.
Decision Date2005-06-06
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IMMEDIA PROTHROMBIN TIME SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Farallon Medial, Inc.. It received FDA 510(k) clearance on 2005-06-06 under 510(k) number K050243. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMEDIA PROTHROMBIN TIME SYSTEM?

IMMEDIA PROTHROMBIN TIME SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-06. The listed applicant is Farallon Medial, Inc.. The 510(k) number is K050243.

When did IMMEDIA PROTHROMBIN TIME SYSTEM receive FDA 510(k) clearance?

IMMEDIA PROTHROMBIN TIME SYSTEM received FDA 510(k) clearance on 2005-06-06, under 510(k) number K050243.

Who is the listed applicant for IMMEDIA PROTHROMBIN TIME SYSTEM?

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

What is the FDA product code for IMMEDIA PROTHROMBIN TIME SYSTEM?

The FDA product code for IMMEDIA PROTHROMBIN TIME SYSTEM is JPA.

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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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