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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chromatographic, Phospholipids
510(k) Number K922792
Device Name ZITHROMAX
Applicant
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232
Applicant Contact DAVID W GATES
Correspondent
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232
Correspondent Contact DAVID W GATES
Regulation Number862.1575
Classification Product Code
JNT  
Date Received06/09/1992
Decision Date 07/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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