Device | AB-CORE K HEPATITIS B CORE ANTIGEN 125I |
Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
Applicant | SORIN BIOMEDICA, FIAT, USA, INC. |
Date Received | 1986-11-18 |
Decision Date | 1987-02-17 |
PMA | P850044 |
Supplement | S003 |
Product Code | LOM |
Advisory Committee | Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | SORIN BIOMEDICA, FIAT, USA, INC. fiat Usa Inc. 375 Park Ave. ny, NY 10152 |