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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, Yeast
510(k) Number K800908
Device Name CAPIK-CANDIDA ALBICANS IDENT. KIT.
Applicant
Immuno-Mycologics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Immuno-Mycologics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.2660
Classification Product Code
JXB  
Date Received04/21/1980
Decision Date 06/02/1980
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
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