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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K944618
Device Name NEONATAL BLOOD COLLECTION AND SCREENING FORM
Applicant
General Business Forms, Inc.
7300 Niles Center Rd.
P.O. Box 457
Skokie,  IL  60077
Applicant Contact FRED RAUMANN
Correspondent
General Business Forms, Inc.
7300 Niles Center Rd.
P.O. Box 457
Skokie,  IL  60077
Correspondent Contact FRED RAUMANN
Regulation Number862.1675
Classification Product Code
JKA  
Date Received09/20/1994
Decision Date 05/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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