Cleared Traditional

Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S

K810078 · Hyland Therapeutic Div., Travenol Laboratories · Chemistry
Feb 1981
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K810078 is an FDA 510(k) clearance for the Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S, 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 February 2, 1981, 20 days after receiving the submission on January 13, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K810078 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1981
Decision Date February 02, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code DIF — Drug Mixture Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

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