Cleared Traditional

SF-CHECK

K952245 · Streck Laboratories, Inc. · Hematology
Sep 1995
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K952245 is an FDA 510(k) clearance for the SF-CHECK, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on September 1, 1995, 112 days after receiving the submission on May 12, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K952245 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1995
Decision Date September 01, 1995
Days to Decision 112 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