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 | DAKO C-KIT PHARMDX |
Generic Name | Immunohistochemistry antibody assay, c-kit |
Regulation Number | 864.1860 |
Applicant | DAKO NORTH AMERICA, INC. 6392 VIA REAL CARPINTERIA, CA 93013 |
PMA Number | P040011 |
Supplement Number | S001 |
Date Received | 03/29/2007 |
Decision Date | 04/23/2007 |
Withdrawal Date
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05/23/2018 |
Product Code |
NKF |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO PERFORM TARGET RETRIEVAL AT AN INCREASED TEMPERATURE AND SHORTER INCUBATION TIME UNDER PRESSURE. |
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