Cleared Abbreviated

DIRECT TIBC CALIBRATOR

K000783 · Reference Diagnostics, Inc. · Chemistry

May 2000

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K000783 is an FDA 510(k) clearance for the DIRECT TIBC CALIBRATOR, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on May 4, 2000, 55 days after receiving the submission on March 10, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number	K000783 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2000
Decision Date	May 04, 2000
Days to Decision	55 days
Submission Type	Abbreviated
Review Panel	Chemistry (CH)
Summary	Statement