Cleared Traditional

BLEEDING TIME DEVICE DISPOSABLE

K830645 · American Dade · Hematology
Mar 1983
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K830645 is an FDA 510(k) clearance for the BLEEDING TIME DEVICE DISPOSABLE, a Device, Bleeding Time (Class II — Special Controls, product code JCA), submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on March 17, 1983, 16 days after receiving the submission on March 1, 1983. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6100.

Submission Details

510(k) Number K830645 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 1983
Decision Date March 17, 1983
Days to Decision 16 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