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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceSPOT-LIGHT HER2 CISH KIT
Classification Namechromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer
Generic Namechromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer
Applicant
INVITROGEN CORPORATION
3175 staley rd.
grand island, NY 14072
PMA NumberP050040
Supplement NumberS002
Date Received03/01/2011
Decision Date04/29/2011
Product Code
NYQ[ Registered Establishments with NYQ ]
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES IN THE PRODUCT INSERT: 1) MANUFACTURING ADDRESS CHANGE; 2) COPYRIGHT CHANGE FROM INVITROGEN CORPORATION TO LIFE TECHNOLOGIES. INVITROGEN WILL REMAIN THE BRAND NAME AND THEREFORE IS STILL INCLUDED ON THE PRODUCT INSERT AND LABELING; AND AN ADDITION OF LITERATURE REFERENCES TO THE BIBLIOGRAPHY.
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