Cleared Traditional

STAK-CHEX

K911582 · Streck Laboratories, Inc. · Hematology
May 1991
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K911582 is an FDA 510(k) clearance for the STAK-CHEX, 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 May 28, 1991, 50 days after receiving the submission on April 8, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K911582 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1991
Decision Date May 28, 1991
Days to Decision 50 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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