K-Assay At-Iii

FDA 510(k) K000361 · Kamiya Biomedical Co.

Substantially Equivalent

510(k) numberK000361

Submission

Device name
K-Assay At-Iii
Applicant
Kamiya Biomedical Co.
Seattle, WA, US
Received
February 4, 2000
Decision date
April 26, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JBQ – Antithrombin Iii Quantitation
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7060
Specialty
Hematology

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K033775Hemosil Liquid Antithrombin XLJBQ · Special Instrumentation Laboratory CO01/02/2004SE
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K994238Il Test Liquid AntithrombinJBQ · Traditional Instrumentation Laboratory CO06/23/2000SE

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Questions and answers

When was K-Assay At-Iii cleared by the FDA?

K-Assay At-Iii (K000361) received a 510(k) decision of Substantially Equivalent on April 26, 2000, 82 days after the submission was received.

What is the product code of K000361?

The FDA product code is JBQ – Antithrombin Iii Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7060.