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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fluorometric method, cpk or isoenzymes
510(k) Number K913298
Device Name AIA-PACK CK-MB
Applicant
TOSOH CORP.
COLUMBIA SQUARE
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact PATRICIA B SHRADER
Correspondent
TOSOH CORP.
COLUMBIA SQUARE
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact PATRICIA B SHRADER
Regulation Number862.1215
Classification Product Code
JHX  
Date Received07/25/1991
Decision Date 09/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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