Cleared Traditional

SURGICUTT - BLEEDING TIME DEVICE

K850542 · International Technidyne Corp. · Hematology
Mar 1985
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K850542 is an FDA 510(k) clearance for the SURGICUTT - BLEEDING TIME DEVICE, a Device, Bleeding Time (Class II — Special Controls, product code JCA), submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on March 1, 1985, 18 days after receiving the submission on February 11, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6100.

Submission Details

510(k) Number K850542 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 1985
Decision Date March 01, 1985
Days to Decision 18 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JCA — Device, Bleeding Time
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6100