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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antistreptolysin - Titer/Streptolysin O Reagent
510(k) Number K926236
Device Name BECKMAN ANTI-STREPTOLYSIN O KIT
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Applicant Contact WILLIAM T RYAN
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Correspondent Contact WILLIAM T RYAN
Regulation Number866.3720
Classification Product Code
GTQ  
Date Received12/11/1992
Decision Date 06/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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