PMA P090026S012

Device: ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S012
Product code: OYA
Decision date: 2014-12-23
Classification: P2psa
Generic name: P2psa
Approval order statement: APPROVAL FOR A CHANGE TO THE CURRENT REAGENT REAL-TIME STABILITY TEST METHOD FOR ACCESS REAGENT PACKS, CALIBRATORS AND SAMPLES DILUENTS TO ENHANCE THE SAFETY AND RELIABILITY OF THE DEVICES PER 21 CFR 814.39(D)(2).

Current openFDA PMA Record#

Device: ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S012
Product code: OYA
Generic name: P2psa
Decision date: 2014-12-23
Decision code: APPR
Date received: 2014-08-25
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE TO THE CURRENT REAGENT REAL-TIME STABILITY TEST METHOD FOR ACCESS REAGENT PACKS, CALIBRATORS AND SAMPLES DILUENTS TO ENHANCE THE SAFETY AND RELIABILITY OF THE DEVICES PER 21 CFR 814.39(D)(2).