Cleared Abbreviated

K052148 - TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
(FDA 510(k) Clearance)

K052148 · Reference Diagnostics, Inc. · Chemistry

Nov 2005

Decision

93d

Days

Class 2

Risk

K052148 is an FDA 510(k) clearance for the TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on November 9, 2005, 93 days after receiving the submission on August 8, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number	K052148 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 2005
Decision Date	November 09, 2005
Days to Decision	93 days
Submission Type	Abbreviated
Review Panel	Chemistry (CH)
Summary	Statement