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 | ER-EIA MONOCLONAL |
Generic Name | KIT, ASSAY, ESTROGEN RECEPTOR |
Regulation Number | 864.1860 |
Applicant | Abbott Laboratories 200 ABBOTT PARK RD. ABBOTT PARK,, IL 60064-3537 |
PMA Number | P850029 |
Supplement Number | S002 |
Date Received | 09/16/1999 |
Decision Date | 09/22/1999 |
Withdrawal Date
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10/15/2003 |
Product Code |
LPJ |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for adding "Caution: This Product Contains Natural Dry Rubber" to labeling. |
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