Cleared Traditional

HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004

K073178 · R&D Systems, Inc. · Hematology
Dec 2007
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K073178 is an FDA 510(k) clearance for the HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 27, 2007, 44 days after receiving the submission on November 13, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K073178 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2007
Decision Date December 27, 2007
Days to Decision 44 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPK — Mixture, Hematology Quality Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625