510(k) K896335

CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR by Creative Laboratory Products, Inc. — Product Code LCP

K896335 is an FDA 510(k) premarket notification submitted by Creative Laboratory Products, Inc. for the device "CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR". The FDA issued a decision of Substantially Equivalent on December 11, 1989. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Creative Laboratory Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1989
Date Received
November 3, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type