Cleared Traditional

QUPID PLUS E.R.

K020378 · Stanbio Laboratory · Chemistry
Jun 2002
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K020378 is an FDA 510(k) clearance for the QUPID PLUS E.R., a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Stanbio Laboratory (Boerne, US). The FDA issued a Cleared decision on June 21, 2002, 136 days after receiving the submission on February 5, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K020378 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2002
Decision Date June 21, 2002
Days to Decision 136 days
Submission Type Traditional
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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