Cleared Traditional

K790027 - SHAKER, MODEL SH-510
(FDA 510(k) Clearance)

K790027 · Sysmex Corp. · Chemistry

Feb 1979

Decision

36d

Days

Class 1

Risk

K790027 is an FDA 510(k) clearance for the SHAKER, MODEL SH-510, a Shaker/stirrer (Class I — General Controls, product code JRQ), submitted by Sysmex Corp. (Mchenry, US). The FDA issued a Cleared decision on February 8, 1979, 36 days after receiving the submission on January 3, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number	K790027 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 03, 1979
Decision Date	February 08, 1979
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—