Cleared Traditional

ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST

K862669 · U. S. Diagnostics, Inc. · General & Plastic Surgery
Oct 1986
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K862669 is an FDA 510(k) clearance for the ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST, a Dermatome (Class I — General Controls, product code GFD), submitted by U. S. Diagnostics, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on October 3, 1986, 81 days after receiving the submission on July 14, 1986. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K862669 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1986
Decision Date October 03, 1986
Days to Decision 81 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GFD — Dermatome
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820