Medical Device Manufacturer · US , Walker , MI

Serono Diagnostics, Inc. - FDA 510(k) Cleared Devices

25 submissions · 25 cleared · Since 1984

25

Total

25

Cleared

0

Denied

FDA 510(k) Regulatory Record - Serono Diagnostics, Inc. Microbiology ✕

4 devices

1-4 of 4

Cleared Apr 29, 1987

MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST

Microbiology · 51d

Cleared Feb 19, 1987

MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT

Microbiology · 92d

Cleared Jul 16, 1986

MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT

Microbiology · 93d

Cleared Jan 28, 1986

MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES

Microbiology · 71d