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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, General Nutrient Broth
510(k) Number K850143
Device Name SPORDEX CULTURE MEDIA
Applicant
American Sterilizer Co.
2424 W. 23rd St.
P.O. Box 620
Erie,  PA  16514
Applicant Contact JAMES A SPALLINA
Correspondent
American Sterilizer Co.
2424 W. 23rd St.
P.O. Box 620
Erie,  PA  16514
Correspondent Contact JAMES A SPALLINA
Regulation Number866.2350
Classification Product Code
JSC  
Date Received01/14/1985
Decision Date 03/05/1985
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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