Cleared Traditional

K963911 - ALPCO/MERCODIA INSULIN ELISA
(FDA 510(k) Clearance)

K963911 · American Laboratory Products Co., Ltd. · Chemistry device

Nov 1996

Decision

32d

Days

Class 1

Risk

K963911 is an FDA 510(k) clearance for the ALPCO/MERCODIA INSULIN ELISA. This device is classified as a Radioimmunoassay, Immunoreactive Insulin (Class I - General Controls, product code CFP).

Submitted by American Laboratory Products Co., Ltd. (Windham, US). The FDA issued a Cleared decision on November 1, 1996, 32 days after receiving the submission on September 30, 1996.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1405.

Submission Details

510(k) Number	K963911 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 30, 1996
Decision Date	November 01, 1996
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement