Cleared Traditional

REFERENCE CHECK, CATALOG NUMBER-RCN-10

K013708 · Precision Biologic · Hematology
Dec 2001
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K013708 is an FDA 510(k) clearance for the REFERENCE CHECK, CATALOG NUMBER-RCN-10, a Plasma, Control, Normal (Class II — Special Controls, product code GIZ), submitted by Precision Biologic (Dartmouth, N.S., CA). The FDA issued a Cleared decision on December 10, 2001, 32 days after receiving the submission on November 8, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K013708 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2001
Decision Date December 10, 2001
Days to Decision 32 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

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