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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 SOUTH KRAEMER BLVD., W-337
BOX 8000
BREA,  CA  92622 -8000
Applicant Contact WILLIAM T RYAN
Correspondent
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-337
BOX 8000
BREA,  CA  92622 -8000
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
Recalls CDRH Recalls
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