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 | QUANTITOPE 125I AFP KIT AND CONTROL SERUM |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | Bio-Rad Laboratories, Inc. 3 Boulevard Raymond Poincare' Marnes-la-Coquette 92430 |
PMA Number | P800025 |
Supplement Number | S003 |
Date Received | 04/01/1985 |
Decision Date | 07/17/1985 |
Withdrawal Date
|
04/03/2009 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Expedited Review Granted? | No |
Combination Product | No |
|
|