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 | HERCEPTEST |
Classification Name | system, test, her-2/neu, ihc |
Generic Name | system, test, her-2/neu, ihc |
Applicant |
DAKO A/S |
42 produktionsvej |
glostrup DK-26-2600 |
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PMA Number | P980018 |
Supplement Number | S018 |
Date Received | 11/21/2013 |
Decision Date | 11/26/2013 |
Product Code | |
Advisory Committee |
Pathology |
Supplement Type | special (immediate track) |
Expedited Review Granted? | No |
Combination Product |
No
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Approval Order Statement
APPROVAL FOR LABELING CHANGES MADE TO ENHANCE SAFETY OF HERCEPTEST. WHEN USED FOR GASTRIC AND GASTROESOPHAGEAL CANCER INDICATIONS. |
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