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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, human chorionic gonadotropin
510(k) Number K003696
Device Name STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD
Applicant
DADE BEHRING, INC.
RT. 896, GLASCOW BLDG. 500
NEWARK,  DE  19714
Applicant Contact LAURENCE A POTTER
Correspondent
DADE BEHRING, INC.
RT. 896, GLASCOW BLDG. 500
NEWARK,  DE  19714
Correspondent Contact LAURENCE A POTTER
Regulation Number862.1155
Classification Product Code
DHA  
Subsequent Product Code
JIT  
Date Received11/30/2000
Decision Date 01/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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