FDA 510(k) Applications for Medical Device Product Code "GMP"
(Antisera, Control For Nontreponemal Tests)

FDA 510(k) Number Applicant Device Name Decision Date
K980638 AMPCOR DIAGNOSTICS, INC. ADI SYPHILIS RPR LIQUID CONTROLS 07/06/1998
K961998 CONSOLIDATED TECHNOLOGIES, INC. QUALITROL SYPHSERO CONTROL SET 08/08/1996
K955143 REMEL, L.P. RPR LIQUID CONTROLS 07/30/1996


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