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FDA 510(k)

DADE THROMBOPLASTIN C PLUS

K-Number: K013155 · 2002-01-18

ApplicantDade Behring, Inc.
Decision Date2002-01-18
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DADE THROMBOPLASTIN C PLUS 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 2002-01-18 under 510(k) number K013155. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE THROMBOPLASTIN C PLUS?

DADE THROMBOPLASTIN C PLUS is a medical device that received FDA 510(k) clearance on 2002-01-18. The listed applicant is Dade Behring, Inc.. The 510(k) number is K013155.

When did DADE THROMBOPLASTIN C PLUS receive FDA 510(k) clearance?

DADE THROMBOPLASTIN C PLUS received FDA 510(k) clearance on 2002-01-18, under 510(k) number K013155.

Who is the listed applicant for DADE THROMBOPLASTIN C PLUS?

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 THROMBOPLASTIN C PLUS?

The FDA product code for DADE THROMBOPLASTIN C PLUS is GJS.

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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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