Cleared Traditional

K780355 - ATROXIN
(FDA 510(k) Clearance)

K780355 · Sigma Chemical Co. · Hematology
Apr 1978
Decision
46d
Days
Class 2
Risk

K780355 is an FDA 510(k) clearance for the ATROXIN, a Bothrops Atrox Reagent (Class II — Special Controls, product code JCO), submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1978, 46 days after receiving the submission on March 3, 1978. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8100.

Submission Details

510(k) Number K780355 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1978
Decision Date April 18, 1978
Days to Decision 46 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JCO — Bothrops Atrox Reagent
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8100