Cleared Traditional

HEMATALL-C PLUS HEMATOLOGY CONTROLS

K863224 · Fisher Scientific Co., LLC · Hematology
Oct 1986
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K863224 is an FDA 510(k) clearance for the HEMATALL-C PLUS HEMATOLOGY CONTROLS, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by Fisher Scientific Co., LLC (Orangeburg, US). The FDA issued a Cleared decision on October 29, 1986, 69 days after receiving the submission on August 21, 1986. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K863224 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1986
Decision Date October 29, 1986
Days to Decision 69 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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