Cleared Traditional

ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500

K020128 · Diagnostic Systems Laboratories, Inc. · Chemistry
Mar 2002
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K020128 is an FDA 510(k) clearance for the ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on March 1, 2002, 45 days after receiving the submission on January 15, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K020128 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 2002
Decision Date March 01, 2002
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHI — Visual, Pregnancy Hcg, Prescription Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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