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FDA 510(k) Applications Submitted by R.SAM NIEDBALA
FDA 510(k) Number
Submission Date
Device Name
Applicant
K011057
04/06/2001
INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
ORASURE TECHNOLOGIES, INC.
K982358
07/06/1998
HISTOFREEZER DEVICE
ORASURE TECHNOLOGIES, INC.
K982801
08/10/1998
AUTO-LYTE PCP EIA, MODEL #1254U
ORASURE TECHNOLOGIES, INC.
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