Cleared Traditional

VITAL SCIENTIFIC PT WITH CALCIUM

K020840 · Vital Scientific N.V. · Hematology
May 2002
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K020840 is an FDA 510(k) clearance for the VITAL SCIENTIFIC PT WITH CALCIUM, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Vital Scientific N.V. (Newton, US). The FDA issued a Cleared decision on May 15, 2002, 61 days after receiving the submission on March 15, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K020840 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2002
Decision Date May 15, 2002
Days to Decision 61 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750