Cleared Traditional

PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG

K926356 · Becton Dickinson Advanced Diagnostics · Chemistry
Mar 1993
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K926356 is an FDA 510(k) clearance for the PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Becton Dickinson Advanced Diagnostics (Sparks, US). The FDA issued a Cleared decision on March 18, 1993, 87 days after receiving the submission on December 21, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K926356 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1992
Decision Date March 18, 1993
Days to Decision 87 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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