Cleared Traditional

ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100

K002128 · Diagnostic Systems Laboratories, Inc. · Chemistry

Dec 2000

Decision

144d

Days

Class 1

Risk

About This 510(k) Submission

K002128 is an FDA 510(k) clearance for the ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100, a Enzyme Immunoassay, Inhibin-a (Class I — General Controls, product code NDR), submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on December 5, 2000, 144 days after receiving the submission on July 14, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1260.

Submission Details

510(k) Number	K002128 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 2000
Decision Date	December 05, 2000
Days to Decision	144 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF