Cleared Traditional

REPTILASE -PC

K843207 · Bio/Data Corp. · Hematology
Oct 1984
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K843207 is an FDA 510(k) clearance for the REPTILASE -PC, a Bothrops Atrox Reagent (Class II — Special Controls, product code JCO), submitted by Bio/Data Corp. (Hatboro, US). The FDA issued a Cleared decision on October 23, 1984, 69 days after receiving the submission on August 15, 1984. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8100.

Submission Details

510(k) Number K843207 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 1984
Decision Date October 23, 1984
Days to Decision 69 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