Cleared Traditional

PARA 5 DIFF

K935196 · Streck Laboratories, Inc. · Hematology
Apr 1994
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K935196 is an FDA 510(k) clearance for the PARA 5 DIFF, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on April 5, 1994, 161 days after receiving the submission on October 26, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K935196 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1993
Decision Date April 05, 1994
Days to Decision 161 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPK — Mixture, Hematology Quality Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625