Note: 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. |
|
Device | CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ] |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 STILLWATER, MN 55082-0285 |
PMA Number | P790032 |
Supplement Number | S002 |
Date Received | 12/24/1990 |
Decision Date | 03/28/1991 |
Withdrawal Date
|
08/19/2002 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
|
|