Cleared Traditional

PARA 12 PLUS RETICS

K000945 · Streck Laboratories, Inc. · Hematology
Apr 2000
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K000945 is an FDA 510(k) clearance for the PARA 12 PLUS RETICS, a Mixture, Control, White-cell And Red-cell Indices (Class II — Special Controls, product code GLQ), submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on April 18, 2000, 26 days after receiving the submission on March 23, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K000945 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2000
Decision Date April 18, 2000
Days to Decision 26 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GLQ — Mixture, Control, White-cell And Red-cell Indices
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625