Cleared Traditional

THERMAJUST CIRCU-TEMP

K780543 · Techhnilab Instruments, Inc. · Chemistry
May 1978
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K780543 is an FDA 510(k) clearance for the THERMAJUST CIRCU-TEMP, a Shaker/stirrer (Class I — General Controls, product code JRQ), submitted by Techhnilab Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 26, 1978, 53 days after receiving the submission on April 3, 1978. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K780543 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1978
Decision Date May 26, 1978
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JRQ — Shaker/stirrer
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050