Cleared Traditional

STATUS HCG SERUM/URINE

K020439 · Princeton BioMeditech Corp. · Chemistry
May 2002
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K020439 is an FDA 510(k) clearance for the STATUS HCG SERUM/URINE, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on May 23, 2002, 101 days after receiving the submission on February 11, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K020439 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2002
Decision Date May 23, 2002
Days to Decision 101 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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