Cleared Traditional

AMERI CLEAR

K832011 · Stephens Scientific · Hematology
Aug 1983
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K832011 is an FDA 510(k) clearance for the AMERI CLEAR, a Agent, Clearing (Class I — General Controls, product code KEM), submitted by Stephens Scientific (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983, 50 days after receiving the submission on June 23, 1983. This device falls under the Hematology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K832011 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1983
Decision Date August 12, 1983
Days to Decision 50 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KEM — Agent, Clearing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010