Cleared Traditional

CHECKPOINT

K931947 · Medical Specialties, Inc. · Hematology
Jun 1993
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K931947 is an FDA 510(k) clearance for the CHECKPOINT, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by Medical Specialties, Inc. (South Plainfield, US). The FDA issued a Cleared decision on June 18, 1993, 60 days after receiving the submission on April 19, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K931947 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1993
Decision Date June 18, 1993
Days to Decision 60 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