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 | ABBOTT ER-EIA MONOCLONAL DIAG. KIT |
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 | S001 |
Date Received | 05/25/1995 |
Decision Date | 07/12/1995 |
Withdrawal Date
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10/15/2003 |
Product Code |
LPJ |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MINOR LABELING CHGS TO ASSIST USERS TO AVOID INTERFERENCE BY METHYLENE BLUE & SIMILAR DYES.CHANGES:REVISED INSTRUCTIONS ON SPECIMEN COLLECTION & SLIDE PREPARATION, INSTRUCTIONS TO REPORT PRESENCE OR ABSENCE OF SURGICAL DYES |
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