Cleared Traditional

PARA TECH PLUS RETICS

K993825 · Streck Laboratories, Inc. · Hematology
Nov 1999
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K993825 is an FDA 510(k) clearance for the PARA TECH PLUS RETICS, a Control, Cell Counter, Normal And Abnormal (Class II — Special Controls, product code JCN), submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on November 30, 1999, 18 days after receiving the submission on November 12, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K993825 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1999
Decision Date November 30, 1999
Days to Decision 18 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JCN — Control, Cell Counter, Normal And Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625