Cleared Traditional

K970933 - AUTO HDL CHOLESTEROL CALIBRATOR
(FDA 510(k) Clearance)

K970933 · Pointe Scientific, Inc., · Chemistry

May 1997

Decision

71d

Days

Class 2

Risk

K970933 is an FDA 510(k) clearance for the AUTO HDL CHOLESTEROL CALIBRATOR, a Calibrator, Primary (Class II — Special Controls, product code JIS), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on May 23, 1997, 71 days after receiving the submission on March 13, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number	K970933 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 1997
Decision Date	May 23, 1997
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement