Cleared Traditional

CALIBRATION VERIFICATION ASSESSMENT (CVA)

K960557 · Streck Laboratories, Inc. · Hematology
Apr 1996
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K960557 is an FDA 510(k) clearance for the CALIBRATION VERIFICATION ASSESSMENT (CVA), 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 April 3, 1996, 54 days after receiving the submission on February 9, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K960557 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 1996
Decision Date April 03, 1996
Days to Decision 54 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