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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Newborn Screening Specimen Collection Paper
510(k) Number K932661
Device Name WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180
Applicant
WHATMAN SPECIALTY PRODUCTS, INC.
6 JUST RD.
FAIRFIELD,  NJ  07004
Applicant Contact RICHARD J COPPOLA
Correspondent
WHATMAN SPECIALTY PRODUCTS, INC.
6 JUST RD.
FAIRFIELD,  NJ  07004
Correspondent Contact RICHARD J COPPOLA
Regulation Number862.1675
Classification Product Code
PJC  
Date Received06/02/1993
Decision Date 04/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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