AMERSHAM AFP

Kit, Test, Alpha-fetoprotein For Neural Tube Defects

FDA Premarket Approval P780006 S003

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: AMERSHAM AFP
• Classification Name: Kit, Test, Alpha-fetoprotein For Neural Tube Defects
• Generic Name: Kit, Test, Alpha-fetoprotein For Neural Tube Defects
• Applicant: ORTHO CLINICAL DIAGNOSTICS
• Date Received: 1989-05-24
• Decision Date: 1989-09-26
• PMA: P780006
• Supplement: S003
• Product Code: LOK
• Advisory Committee: Immunology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: ORTHO CLINICAL DIAGNOSTICS 100 Indigo Creek Drive rochester, NY 14626-5101

Supplemental Filings

Supplement Number	Date	Supplement Type
P780006		Original Filing
S003	1989-05-24	Normal 180 Day Track
S002	1985-10-31
S001