Cleared Traditional

K914820 - DSL INSULIN RIA (DSL 1600)
(FDA 510(k) Clearance)

K914820 · Diagnostic Systems Laboratories, Inc. · Chemistry device

Jan 1992

Decision

76d

Days

Class 1

Risk

K914820 is an FDA 510(k) clearance for the DSL INSULIN RIA (DSL 1600). This device is classified as a Radioimmunoassay, Immunoreactive Insulin (Class I - General Controls, product code CFP).

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on January 9, 1992, 76 days after receiving the submission on October 25, 1991.

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

Submission Details

510(k) Number	K914820 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 25, 1991
Decision Date	January 09, 1992
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement