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 | ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER |
Generic Name | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER |
Regulation Number | 866.6010 |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. AP5N-2, DEPT. 09VB ABBOTT PARK, IL 60064-3500 |
PMA Number | P820060 |
Supplement Number | S003 |
Date Received | 05/15/1986 |
Decision Date | 03/09/1987 |
Withdrawal Date
|
11/15/2013 |
Product Code |
LOJ |
Advisory Committee |
Immunology |
Expedited Review Granted? | No |
Combination Product | No |
|
|