Cleared Abbreviated

BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST

K023944 · Bayer Corp. · Chemistry
Feb 2003
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K023944 is an FDA 510(k) clearance for the BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Bayer Corp. (Medfield, US). The FDA issued a Cleared decision on February 11, 2003, 77 days after receiving the submission on November 26, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K023944 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2002
Decision Date February 11, 2003
Days to Decision 77 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

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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