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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 K934271
Device Name BECKMAN SYNCHRON LACTATE REAGENT
Applicant
Beckman-Diagnostic Systems Group
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92821
Applicant Contact WILLIAM T RYAN
Correspondent
Beckman-Diagnostic Systems Group
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92821
Correspondent Contact WILLIAM T RYAN
Regulation Number862.1450
Classification Product Code
KHP  
Date Received08/31/1993
Decision Date 11/09/1993
Decision Substantially Equivalent (SESE)
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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