AB-CORE K HEPATITIS B CORE ANTIGEN 125I

FDA Premarket Approval P850044 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

• 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: 1986-07-03
• Decision Date: 1986-08-26
• PMA: P850044
• Supplement: S001
• Product Code: LOM
• Advisory Committee: Microbiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: SORIN BIOMEDICA, FIAT, USA, INC. fiat Usa Inc. 375 Park Ave. ny, NY 10152

Supplemental Filings

Supplement Number	Date	Supplement Type
P850044		Original Filing
S003	1986-11-18	Normal 180 Day Track
S002	1986-08-01	Normal 180 Day Track
S001	1986-07-03	Normal 180 Day Track