510(k) K821192

YSI #24 & 24M GLUCOSE ANALYZERS by Yellow Springs Instrument Co., Inc. — Product Code CGA

K821192 is an FDA 510(k) premarket notification submitted by Yellow Springs Instrument Co., Inc. for the device "YSI #24 & 24M GLUCOSE ANALYZERS". The FDA issued a decision of Substantially Equivalent on June 14, 1982. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Yellow Springs Instrument Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1982
Date Received
April 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type