Cleared Traditional

THROMBOPLASTIN.R

K864274 · American Dade · Hematology
Nov 1986
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K864274 is an FDA 510(k) clearance for the THROMBOPLASTIN.R, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on November 13, 1986, 15 days after receiving the submission on October 29, 1986. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K864274 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 1986
Decision Date November 13, 1986
Days to Decision 15 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750