Cleared Traditional

CRYOCHECK WEAK LUPUS POSITIVE CONTROL

K032804 · Precision Biologic · Hematology
Nov 2003
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K032804 is an FDA 510(k) clearance for the CRYOCHECK WEAK LUPUS POSITIVE CONTROL, a Control, Plasma, Abnormal (Class II — Special Controls, product code GGC), submitted by Precision Biologic (Dartmouth, N.S., CA). The FDA issued a Cleared decision on November 3, 2003, 55 days after receiving the submission on September 9, 2003. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K032804 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2003
Decision Date November 03, 2003
Days to Decision 55 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGC — Control, Plasma, Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425