AUTODELFIA HAFP TEST SYSTEM

Kit, Test, Alpha-fetoprotein For Neural Tube Defects

FDA Premarket Approval P970037 S008

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

Second alternative type of topo (trioctylphosphine oxide) raw material type used in the manufacturing of the enhancement solution for the device.

• Device: AUTODELFIA HAFP TEST SYSTEM
• Classification Name: Kit, Test, Alpha-fetoprotein For Neural Tube Defects
• Generic Name: Kit, Test, Alpha-fetoprotein For Neural Tube Defects
• Applicant: PerkinElmer, Inc.
• Date Received: 2012-05-15
• Decision Date: 2012-06-14
• PMA: P970037
• Supplement: S008
• Product Code: LOK
• Advisory Committee: Immunology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: PerkinElmer, Inc. 940 Winter Street waltham, MA 02451

Supplemental Filings

Supplement Number	Date	Supplement Type
P970037		Original Filing
S012	2021-07-15	30-day Notice
S011	2018-08-09	30-day Notice
S010	2017-05-11	30-day Notice
S009	2016-07-27	30-day Notice
S008	2012-05-15	30-day Notice
S007	2011-09-23	135 Review Track For 30-day Notice
S006	2011-06-13	30-day Notice
S005	2011-03-17	30-day Notice
S004	2011-02-02	30-day Notice
S003	2010-03-01	Normal 180 Day Track
S002	2008-09-17	Normal 180 Day Track
S001	2002-10-18	Special (immediate Track)

NIH GUDID Devices

Device ID	PMA	Supp
06438147321322	P970037	000
06438147321315	P970037	000