Cleared Traditional

K915200 - PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA
(FDA 510(k) Clearance)

K915200 · Becton Dickinson Advanced Diagnostics · Chemistry device

Dec 1991

Decision

27d

Days

Class 2

Risk

K915200 is an FDA 510(k) clearance for the PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA. This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).

Submitted by Becton Dickinson Advanced Diagnostics (Cockeysville, US). The FDA issued a Cleared decision on December 16, 1991, 27 days after receiving the submission on November 19, 1991.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number	K915200 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 19, 1991
Decision Date	December 16, 1991
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement