Cleared Traditional

K964635 - NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT
(FDA 510(k) Clearance)

K964635 · Nichols Institute Diagnostics · Chemistry

May 1997

Decision

183d

Days

Class 2

Risk

K964635 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT. This device is classified as a Radioimmunoassay, Calcitonin (Class II — Special Controls, product code JKR).

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on May 21, 1997, 183 days after receiving the submission on November 19, 1996.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1140.

Submission Details

510(k) Number	K964635 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 1996
Decision Date	May 21, 1997
Days to Decision	183 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement