PMA P850029S001

Device: ABBOTT ER-EIA MONOCLONAL DIAG. KIT
Applicant: Abbott Laboratories
PMA number: P850029
Supplement: S001
Product code: LPJ
Decision date: 1995-07-12
Generic name: KIT, ASSAY, ESTROGEN RECEPTOR
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

Current openFDA PMA Record

Device: ABBOTT ER-EIA MONOCLONAL DIAG. KIT
Applicant: Abbott Laboratories
PMA number: P850029
Supplement: S001
Product code: LPJ
Generic name: KIT, ASSAY, ESTROGEN RECEPTOR
Decision date: 1995-07-12
Decision code: APPR
Date received: 1995-05-25
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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