Cleared Traditional

K944325 - LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN (FDA 510(k) Clearance)

K944325 · Princeton BioMeditech Corp. · Chemistry device

Feb 1995

Decision

173d

Days

Class 2

Risk

K944325 is an FDA 510(k) clearance for the LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN. This device is classified as a U.v. Method, Cpk Isoenzymes (Class II - Special Controls, product code JHW).

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on February 22, 1995, 173 days after receiving the submission on September 2, 1994.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number	K944325 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 02, 1994
Decision Date	February 22, 1995
Days to Decision	173 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement

Device Classification

Product Code	JHW — U.v. Method, Cpk Isoenzymes
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 862.1215