Cleared Traditional

K051888 - TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
(FDA 510(k) Clearance)

K051888 · Scantibodies Laboratory, Inc. · Chemistry

Oct 2005

Decision

98d

Days

Class 2

Risk

K051888 is an FDA 510(k) clearance for the TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013. This device is classified as a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW).

Submitted by Scantibodies Laboratory, Inc. (Santee, US). The FDA issued a Cleared decision on October 18, 2005, 98 days after receiving the submission on July 12, 2005.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number	K051888 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2005
Decision Date	October 18, 2005
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement