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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, identification, enterobacteriaceae
510(k) Number K811765
Device Name SENSITITIRE AP60
Applicant
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number866.2660
Classification Product Code
JSS  
Date Received06/22/1981
Decision Date 08/13/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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