Bioclot Apc Sensitivity

FDA 510(k) K983898 · Biopool Intl., Inc.

Substantially Equivalent

510(k) numberK983898

Submission

Device name
Bioclot Apc Sensitivity
Applicant
Biopool Intl., Inc.
Ventura, CA, US
Received
November 3, 1998
Decision date
January 6, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GGP – Test, Qualitative And Quantitative Factor Deficiency
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7290
Specialty
Hematology

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Questions and answers

When was Bioclot Apc Sensitivity cleared by the FDA?

Bioclot Apc Sensitivity (K983898) received a 510(k) decision of Substantially Equivalent on January 6, 1999, 64 days after the submission was received.

What is the product code of K983898?

The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.