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Serono Diagnostics, Inc.

25 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS (K953598)Serono Diagnostics, Inc.1996-03-11
SR1 DHEA-S ENZYME IMMUNOASSAY (K942051)Serono Diagnostics, Inc.1994-07-13
T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS (K883085)Serono Diagnostics, Inc.1988-09-09
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA (K882340)Serono Diagnostics, Inc.1988-08-08
T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE (K880388)Serono Diagnostics, Inc.1988-03-03
T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE (K874866)Serono Diagnostics, Inc.1988-02-11
PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH (K873431)Serono Diagnostics, Inc.1987-10-20
LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA (K873186)Serono Diagnostics, Inc.1987-09-29
PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA (K873400)Serono Diagnostics, Inc.1987-09-25
PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS (K872862)Serono Diagnostics, Inc.1987-09-18
HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE (K873033)Serono Diagnostics, Inc.1987-09-14
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE (K872727)Serono Diagnostics, Inc.1987-08-05
TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA. (K872897)Serono Diagnostics, Inc.1987-07-31
FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH (K872627)Serono Diagnostics, Inc.1987-07-21
MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST (K870946)Serono Diagnostics, Inc.1987-04-29
MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT (K864565)Serono Diagnostics, Inc.1987-02-19
TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP (K864677)Serono Diagnostics, Inc.1987-01-07
FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT (K862813)Serono Diagnostics, Inc.1986-09-16
HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS (K862262)Serono Diagnostics, Inc.1986-07-29
MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT (K861379)Serono Diagnostics, Inc.1986-07-16
ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE (K861361)Serono Diagnostics, Inc.1986-06-27
MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES (K854615)Serono Diagnostics, Inc.1986-01-28
GASTRIN RADIOIMMUNOASSAY TEST KIT (K842965)Serono Diagnostics, Inc.1984-10-11
RENIN RADIOIMMUNOASSAY TEST KIT (K842966)Serono Diagnostics, Inc.1984-10-11
C-PEPTIDE RADIOIMMUNOASSAY TEST KIT (K833396)Serono Diagnostics, Inc.1984-04-13

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Every clearance here is in the API, with alerts when new ones post.