FDA 510(k) Applications Submitted by ALFA BIOTECH (UK) LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K980574 02/17/1998 AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0 ALFA BIOTECH (UK) LTD.
K974505 12/01/1997 AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501 ALFA BIOTECH (UK) LTD.
K974027 10/23/1997 AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK ALFA BIOTECH (UK) LTD.


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