CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ]

FDA Premarket Approval P790032 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

DeviceCLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ]
Generic NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
ApplicantINCSTAR CORP.
Date Received1991-02-26
Decision Date1993-07-23
PMAP790032
SupplementS003
Product CodeLOK 
Advisory CommitteeImmunology
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address INCSTAR CORP. 1990 Insustrial Blvd. p.o. Box 285 stillwater, MN 55082-0285

Supplemental Filings

Supplement NumberDateSupplement Type
P790032Original Filing
S003 1991-02-26 Normal 180 Day Track
S002 1990-12-24 Normal 180 Day Track
S001 1986-06-10 Special (immediate Track)

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