Cleared Traditional

HEMA-TROL Q-CHECK

K952385 · Medical Specialties Intl., Inc. · Hematology
Sep 1995
Decision
126d
Days
Class 1
Risk

About This 510(k) Submission

K952385 is an FDA 510(k) clearance for the HEMA-TROL Q-CHECK, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Medical Specialties Intl., Inc. (South Plainfield, US). The FDA issued a Cleared decision on September 25, 1995, 126 days after receiving the submission on May 22, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K952385 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1995
Decision Date September 25, 1995
Days to Decision 126 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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