Cleared Traditional

K060968 - STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW
(FDA 510(k) Clearance)

K060968 · Wortham Laboratories, Inc. · Hematology
May 2007
Decision
403d
Days
Class 2
Risk

K060968 is an FDA 510(k) clearance for the STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW, a Plasma, Control, Normal (Class II — Special Controls, product code GIZ), submitted by Wortham Laboratories, Inc. (Chattanooga, US). The FDA issued a Cleared decision on May 15, 2007, 403 days after receiving the submission on April 7, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K060968 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2006
Decision Date May 15, 2007
Days to Decision 403 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GIZ — Plasma, Control, Normal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425