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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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New Search Biologics Premarket Approvals (PMAs) Back to Search Results
Note: this medical device record is a supplement.
 
Device Ortho HBc Antibody ELISA Test System
Classification Namesystem, identification, hepatitis b antigen
Generic Nameidentification system for hepatitis b antigen
Applicant
Ortho-Clinical Diagnostics, Inc.
1001 u.s. highway 202 p.o. box 350
Raritan , NJ 08869 -0606
  
PMA NumberBP870003
Supplement NumberS002
Date Received02/17/1989
Decision Date01/10/1991
Decision Approved
Product Code
KSJ[ Registered Establishments with KSJ ]
Advisory Committee Hematology
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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