Cleared Traditional

K896033 - FDP COLLECTION TUBES
(FDA 510(k) Clearance)

K896033 · Medical Diagnostic Technologies, Inc. · Hematology
Oct 1989
Decision
11d
Days
Class 2
Risk

K896033 is an FDA 510(k) clearance for the FDP COLLECTION TUBES, a Bothrops Atrox Reagent (Class II — Special Controls, product code JCO), submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on October 27, 1989, 11 days after receiving the submission on October 16, 1989. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8100.

Submission Details

510(k) Number K896033 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 1989
Decision Date October 27, 1989
Days to Decision 11 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