Cleared Traditional

HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE

K041728 · Immunostics Inc., · Chemistry
Aug 2004
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K041728 is an FDA 510(k) clearance for the HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on August 11, 2004, 47 days after receiving the submission on June 25, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K041728 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2004
Decision Date August 11, 2004
Days to Decision 47 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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