Cleared Traditional

IMMUNOCARD HCG ONE STEP (I-S) TEST KIT

K911826 · Disease Detection International, Inc. · Chemistry
Jul 1991
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K911826 is an FDA 510(k) clearance for the IMMUNOCARD HCG ONE STEP (I-S) TEST KIT, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Disease Detection International, Inc. (Irvine, US). The FDA issued a Cleared decision on July 19, 1991, 86 days after receiving the submission on April 24, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K911826 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1991
Decision Date July 19, 1991
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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