510(k) K832750

EASYTOUCH HEMOGLOBIN REAGENT by Worthington Diagnostic Systems — Product Code KHG

K832750 is an FDA 510(k) premarket notification submitted by Worthington Diagnostic Systems for the device "EASYTOUCH HEMOGLOBIN REAGENT". The FDA issued a decision of Substantially Equivalent on September 26, 1983. The device falls under product code KHG (Whole Blood Hemoglobin Determination), a Class II device regulated under 21 CFR 864.7500. Worthington Diagnostic Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1983
Date Received
August 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Whole Blood Hemoglobin Determination
Device Class
Class II
Regulation Number
864.7500
Review Panel
HE
Submission Type