Cleared Traditional

HEMATOLOGY CONTROL

K895373 · Medical Specialties Intl., Inc. · Hematology
Oct 1989
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K895373 is an FDA 510(k) clearance for the HEMATOLOGY CONTROL, a Control, Cell Counter, Normal And Abnormal (Class II — Special Controls, product code JCN), submitted by Medical Specialties Intl., Inc. (South Plainfield, US). The FDA issued a Cleared decision on October 6, 1989, 38 days after receiving the submission on August 29, 1989. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K895373 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1989
Decision Date October 06, 1989
Days to Decision 38 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