Cleared Traditional

CELL-CHEX

K000076 · Streck Laboratories, Inc. · Hematology
Mar 2000
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K000076 is an FDA 510(k) clearance for the CELL-CHEX, a Control, Red-cell (Class II — Special Controls, product code GJR), submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on March 3, 2000, 53 days after receiving the submission on January 10, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K000076 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2000
Decision Date March 03, 2000
Days to Decision 53 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

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