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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name blood establishment computer software and accessories
510(k) Number BK990008
Tradename Rubin & Poor Configurable Manual Blot System 1.0C
Original Applicant
Rubin & Poor, Inc.
155 maplewood avenue #5
maplewood,  NJ  07040 US
Current 510(k) Holder *
155 maplewood ave, #5
maplewood,  NJ  07040
Current 510(k) Contact * jonathan poor
Regulation Number864.9165
Classification Product Code
Date Received03/22/1999
Decision Date 10/29/1999
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
* Based on currently available data in Establishment Registration and Device Listing