Cleared Traditional

SMAC SYSTEM

K770508 · Mid Tech, Inc. · Chemistry
May 1977
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K770508 is an FDA 510(k) clearance for the SMAC SYSTEM, a Ph Buffer (Class I — General Controls, product code JCC), submitted by Mid Tech, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1977, 53 days after receiving the submission on March 17, 1977. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K770508 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1977
Decision Date May 09, 1977
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JCC — Ph Buffer
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010