Serono Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 25
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K953598 | SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS | March 11, 1996 |
| K942051 | SR1 DHEA-S ENZYME IMMUNOASSAY | July 13, 1994 |
| K883085 | T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS | September 9, 1988 |
| K882340 | LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA | August 8, 1988 |
| K880388 | T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE | March 3, 1988 |
| K874866 | T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE | February 11, 1988 |
| K873431 | PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH | October 20, 1987 |
| K873186 | LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA | September 29, 1987 |
| K873400 | PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA | September 25, 1987 |
| K872862 | PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS | September 18, 1987 |
| K873033 | HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE | September 14, 1987 |
| K872727 | LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE | August 5, 1987 |
| K872897 | TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA. | July 31, 1987 |
| K872627 | FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH | July 21, 1987 |
| K870946 | MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST | April 29, 1987 |
| K864565 | MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT | February 19, 1987 |
| K864677 | TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP | January 7, 1987 |
| K862813 | FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT | September 16, 1986 |
| K862262 | HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS | July 29, 1986 |
| K861379 | MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT | July 16, 1986 |