Cleared Traditional

K921206 - HCG CONTROL
(FDA 510(k) Clearance)

K921206 · Polymedco, Inc. · Chemistry

Apr 1992

Decision

47d

Days

Class 1

Risk

K921206 is an FDA 510(k) clearance for the HCG CONTROL. This device is classified as a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX).

Submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on April 29, 1992, 47 days after receiving the submission on March 13, 1992.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K921206 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 1992
Decision Date	April 29, 1992
Days to Decision	47 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement