Cleared Traditional

CD-CHEX + RBC

K960894 · Streck Laboratories, Inc. · Hematology
May 1996
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K960894 is an FDA 510(k) clearance for the CD-CHEX + RBC, a Control, White-cell (Class II — Special Controls, product code GGL), submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on May 24, 1996, 80 days after receiving the submission on March 5, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K960894 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1996
Decision Date May 24, 1996
Days to Decision 80 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGL — Control, White-cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625