510(k) K771102

UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS by The Dow Chemical Co. — Product Code LFR

K771102 is an FDA 510(k) premarket notification submitted by The Dow Chemical Co. for the device "UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS". The FDA issued a decision of Substantially Equivalent on November 22, 1977. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. The Dow Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1977
Date Received
June 20, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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