Cleared Traditional

COAGULATION CONTROL, LEVEL II

K870686 · U. S. Diagnostics, Inc. · Hematology
Apr 1987
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K870686 is an FDA 510(k) clearance for the COAGULATION CONTROL, LEVEL II, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by U. S. Diagnostics, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on April 20, 1987, 60 days after receiving the submission on February 19, 1987. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K870686 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1987
Decision Date April 20, 1987
Days to Decision 60 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JPA — System, Multipurpose For In Vitro Coagulation Studies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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