Cleared Traditional

K050576 - MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H
(FDA 510(k) Clearance)

K050576 · Good Biotech Corp. · Chemistry device
Apr 2005
Decision
45d
Days
Class 2
Risk

K050576 is an FDA 510(k) clearance for the MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H. This device is classified as a Albumin, Fitc, Antigen, Antiserum, Control (Class II - Special Controls, product code DDZ).

Submitted by Good Biotech Corp. (Taichung, TW). The FDA issued a Cleared decision on April 21, 2005, 45 days after receiving the submission on March 7, 2005.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5040.

Submission Details

510(k) Number K050576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2005
Decision Date April 21, 2005
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DDZ — Albumin, Fitc, Antigen, Antiserum, Control
Device Class Class II - Special Controls
CFR Regulation 21 CFR 866.5040