Cleared Traditional

K994227 - ADVANTAGE HCG TEST (URINE/SERUM)
(FDA 510(k) Clearance)

K994227 · Advantage Diagnostics Corp. · Chemistry

Feb 2000

Decision

50d

Days

Class 2

Risk

K994227 is an FDA 510(k) clearance for the ADVANTAGE HCG TEST (URINE/SERUM). This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI).

Submitted by Advantage Diagnostics Corp. (Mountian View, US). The FDA issued a Cleared decision on February 3, 2000, 50 days after receiving the submission on December 15, 1999.

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

Submission Details

510(k) Number	K994227 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 1999
Decision Date	February 03, 2000
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF