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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Lactic, Enzymatic Method
510(k) Number K901131
Device Name YSI MODEL 1500 SPORT L-LACTATE ANALYZER
Applicant
Yellow Springs Instrument Co., Inc.
1725 Brannum Ln.
Yellow Springs,  OH  45387
Applicant Contact FRED BREIDT
Correspondent
Yellow Springs Instrument Co., Inc.
1725 Brannum Ln.
Yellow Springs,  OH  45387
Correspondent Contact FRED BREIDT
Regulation Number862.1450
Classification Product Code
KHP  
Date Received03/12/1990
Decision Date 08/27/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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