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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Immunoperoxidase, Chlamydia Spp.
510(k) Number K893669
Device Name CELLMATICS SHLAMYDIA DETECTION SYSTEM
Applicant
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232
Applicant Contact ROBERT
Correspondent
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232
Correspondent Contact ROBERT
Regulation Number866.3120
Classification Product Code
LKH  
Date Received05/15/1989
Decision Date 06/23/1989
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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