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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Fluorescent, Chlamydia Trachomatis
510(k) Number K860179
Device Name CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT
Applicant
Difco Laboratories, Inc.
1180 Ellsworth Rd.
Ann Arbor,  MI  48104
Applicant Contact WALTER S FISHER
Correspondent
Difco Laboratories, Inc.
1180 Ellsworth Rd.
Ann Arbor,  MI  48104
Correspondent Contact WALTER S FISHER
Regulation Number866.3120
Classification Product Code
LJP  
Date Received01/17/1986
Decision Date 03/10/1986
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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