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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K864727
Device Name CULT-UR
Applicant
R.P. Laboratories, Inc.
55 Commerce Rd.
Cedar Grove,  NJ  07009
Applicant Contact LEAMAN, JR
Correspondent
R.P. Laboratories, Inc.
55 Commerce Rd.
Cedar Grove,  NJ  07009
Correspondent Contact LEAMAN, JR
Regulation Number866.2900
Classification Product Code
LIO  
Date Received12/02/1986
Decision Date 01/05/1987
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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