PMA P900013S001

Device: ABBOTT PGR-EIA MONOCLONAL
Applicant: Abbott Laboratories
PMA number: P900013
Supplement: S001
Product code: LPI
Decision date: 1995-07-07
Generic name: KIT, ASSAY, PROGESTERONE RECEPTOR
Approval order statement: MINOR LABELING CHANGES TO ASSIST USERS IN AVOIDING INTERFERENCE BY METHYLENE BLUE & SIMILAR DYES.CHANGES:REVISED INSTRUCTIONS ON SPECIMEN COLLECTION & SLIDE PREPARATION,ADDING REFERENCE ON THE EFFECT OF METHYLENE BLUE ON ESTROGEN RECEPTORS

Current openFDA PMA Record

Device: ABBOTT PGR-EIA MONOCLONAL
Applicant: Abbott Laboratories
PMA number: P900013
Supplement: S001
Product code: LPI
Generic name: KIT, ASSAY, PROGESTERONE RECEPTOR
Decision date: 1995-07-07
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 CHANGES TO ASSIST USERS IN AVOIDING INTERFERENCE BY METHYLENE BLUE & SIMILAR DYES.CHANGES:REVISED INSTRUCTIONS ON SPECIMEN COLLECTION & SLIDE PREPARATION,ADDING REFERENCE ON THE EFFECT OF METHYLENE BLUE ON ESTROGEN RECEPTORS