Cleared Traditional

HUMAN CHORIONIC GONADOTROPIN METHOD

K970387 · Dade Chemistry Systems, Inc. · Chemistry
Mar 1997
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K970387 is an FDA 510(k) clearance for the HUMAN CHORIONIC GONADOTROPIN METHOD, a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA), submitted by Dade Chemistry Systems, Inc. (Glasgow, US). The FDA issued a Cleared decision on March 10, 1997, 35 days after receiving the submission on February 3, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K970387 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1997
Decision Date March 10, 1997
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DHA — System, Test, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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