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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K920767
Device Name NYCOPLASTIN
Applicant
Nycomed Pharma AS
Sandakerv. 74
P.O. Box 4284 Torshov
N-40401 Oslo 4, Norway,  NO
Applicant Contact JORUNN LOLLAND
Correspondent
Nycomed Pharma AS
Sandakerv. 74
P.O. Box 4284 Torshov
N-40401 Oslo 4, Norway,  NO
Correspondent Contact JORUNN LOLLAND
Regulation Number864.7750
Classification Product Code
GJS  
Date Received02/19/1992
Decision Date 02/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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