Cleared Traditional

K810077 - OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.
(FDA 510(k) Clearance)

K810077 · Hyland Therapeutic Div., Travenol Laboratories · Chemistry

Jan 1981

Decision

15d

Days

Class 1

Risk

K810077 is an FDA 510(k) clearance for the OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.. This device is classified as a Drug Mixture Control Materials (Class I — General Controls, product code DIF).

Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on January 28, 1981, 15 days after receiving the submission on January 13, 1981.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number	K810077 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 1981
Decision Date	January 28, 1981
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—