Cleared Traditional

HDL CHOLESTEROL-E

K863065 · J. D. Assoc. · Chemistry

Sep 1986

Decision

44d

Days

—

Risk

About This 510(k) Submission

K863065 is an FDA 510(k) clearance for the HDL CHOLESTEROL-E, submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on September 25, 1986, 44 days after receiving the submission on August 12, 1986. This device falls under the Chemistry review panel.

Submission Details

510(k) Number	K863065 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 1986
Decision Date	September 25, 1986
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—