Cleared Traditional

STAK-CHEX PLUS RETICS

K992887 · Streck Laboratories, Inc. · Hematology
Nov 1999
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K992887 is an FDA 510(k) clearance for the STAK-CHEX 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 November 22, 1999, 87 days after receiving the submission on August 27, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K992887 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1999
Decision Date November 22, 1999
Days to Decision 87 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