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. |
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Device | RAPID FFN FOR THE TLIIQ SYSTEM |
Generic Name | ENZYME IMMUNOASSAY, FETAL FIBRONECTIN |
Applicant | HOLOGIC, INC. 1240 Elko Drive Sunnyvale, CA 94089 |
PMA Number | P920048 |
Supplement Number | S006 |
Date Received | 09/29/2008 |
Decision Date | 10/22/2008 |
Product Code |
LKV |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ALTERNATIVE MANUFACTURING PROCESS FOR THE RAPID FFN CASSETTE. |
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