Cleared Traditional

Q.I.C. BLEEDING TIME DEVICE

K871318 · Helena Laboratories · Hematology
Jun 1987
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K871318 is an FDA 510(k) clearance for the Q.I.C. BLEEDING TIME DEVICE, a Device, Bleeding Time (Class II — Special Controls, product code JCA), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on June 10, 1987, 68 days after receiving the submission on April 3, 1987. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6100.

Submission Details

510(k) Number K871318 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1987
Decision Date June 10, 1987
Days to Decision 68 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