Cleared Traditional

INSURE PREGNANCY TEST

K991515 · Inbios Intl., Inc. · Chemistry
May 1999
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K991515 is an FDA 510(k) clearance for the INSURE PREGNANCY TEST, a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA), submitted by Inbios Intl., Inc. (Seattle, US). The FDA issued a Cleared decision on May 28, 1999, 28 days after receiving the submission on April 30, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K991515 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 1999
Decision Date May 28, 1999
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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