PMA P820060S017

Device: AFP CONTROL PACK
Applicant: Abbott Laboratories
PMA number: P820060
Supplement: S017
Product code: LOJ
Decision date: 2003-03-05
Classification: Immunology
Generic name: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Approval order statement: APPROVAL FOR INITIATING HEAT STRESS REFERENCE TESTING FOR THE PLASMA DIAGNOSTIC BASE (PDB; CONTROL DILUENT) USED IN THE PREPARATION OF THE CONTROLS FOR THE AFP ASSAYS.

Current openFDA PMA Record#

Device: AFP CONTROL PACK
Applicant: Abbott Laboratories
PMA number: P820060
Supplement: S017
Product code: LOJ
Generic name: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Decision date: 2003-03-05
Decision code: APPR
Date received: 2003-01-30
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR INITIATING HEAT STRESS REFERENCE TESTING FOR THE PLASMA DIAGNOSTIC BASE (PDB; CONTROL DILUENT) USED IN THE PREPARATION OF THE CONTROLS FOR THE AFP ASSAYS.