PMA P820060S011

Device: ABBOTT AXSYM AFP
Applicant: Abbott Laboratories
PMA number: P820060
Supplement: S011
Product code: LOJ
Decision date: 1997-05-16
Generic name: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Approval order statement: APPROVAL FOR THE ADDITION OF A SYSTEM PERFORMED AUTOMATED DILUTION PROTOCOL FOR A 1:101 SAMPLE DILUTION OF AMNIOTIC FLUID AND IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN: 1)HUMAN SERUM OR PLASMA TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOUS TESTICULAR CANCER. (2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION OT AID INT HE DETECTION OF FETAL OPEN NEURAL TUBE DETECTS (NTD). TEST RESULTS WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY OR AMNIOGRAPHY ARE A SAFE AND EFFECTIVE AID IN THE DETECTION OF FETAL OPEN NTD.

Current openFDA PMA Record

Device: ABBOTT AXSYM AFP
Applicant: Abbott Laboratories
PMA number: P820060
Supplement: S011
Product code: LOJ
Generic name: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Decision date: 1997-05-16
Decision code: APPR
Date received: 1997-04-21
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF A SYSTEM PERFORMED AUTOMATED DILUTION PROTOCOL FOR A 1:101 SAMPLE DILUTION OF AMNIOTIC FLUID AND IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN: 1)HUMAN SERUM OR PLASMA TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOUS TESTICULAR CANCER. (2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION OT AID INT HE DETECTION OF FETAL OPEN NEURAL TUBE DETECTS (NTD). TEST RESULTS WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY OR AMNIOGRAPHY ARE A SAFE AND EFFECTIVE AID IN THE DETECTION OF FETAL OPEN NTD.