Cleared Traditional

PRO-STEP PT HCG

K925303 · Disease Detection International, Inc. · Chemistry
Jun 1993
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K925303 is an FDA 510(k) clearance for the PRO-STEP PT HCG, 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 June 15, 1993, 237 days after receiving the submission on October 21, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K925303 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1992
Decision Date June 15, 1993
Days to Decision 237 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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