510(k) K852261

YSI MODEL 2372 TOTAL BLOOD LACTATE KIT by Yellow Springs Instrument Co., Inc. — Product Code KHP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1985
Date Received
May 24, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Lactic, Enzymatic Method
Device Class
Class I
Regulation Number
862.1450
Review Panel
CH
Submission Type