Cleared Traditional

ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.

K052694 · Ind Diagnostic, Inc. · Chemistry
Dec 2005
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K052694 is an FDA 510(k) clearance for the ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES., a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Ind Diagnostic, Inc. (Delta, B.C., CA). The FDA issued a Cleared decision on December 16, 2005, 79 days after receiving the submission on September 28, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K052694 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2005
Decision Date December 16, 2005
Days to Decision 79 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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