Company ยท US
Serono Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1996. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 |
| CIB | Radioimmunoassay, Angiotensin I And Renin | 1 |
| GKZ | Counter, Differential Cell | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 |
| JKD | Radioimmunoassay, C-Peptides Of Proinsulin | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 1 |
| LKI | Antisera, Fluorescent, Chlamydia Spp. | 1 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 11, 1996 | K953598 | SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS Serono Diagnostics, Inc. | GKZ |
| Jul 13, 1994 | K942051 | SR1 DHEA-S ENZYME IMMUNOASSAY Serono Diagnostics, Inc. | JKC |
| Sep 9, 1988 | K883085 | T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS Serono Diagnostics, Inc. | KHQ |
| Aug 8, 1988 | K882340 | LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA Serono Diagnostics, Inc. | CEP |
| Mar 3, 1988 | K880388 | T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE Serono Diagnostics, Inc. | CDP |
| Feb 11, 1988 | K874866 | T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE Serono Diagnostics, Inc. | KLI |
| Oct 20, 1987 | K873431 | PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH Serono Diagnostics, Inc. | JLS |
| Sep 29, 1987 | K873186 | LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA Serono Diagnostics, Inc. | CEP |
| Sep 25, 1987 | K873400 | PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA Serono Diagnostics, Inc. | CFT |
| Sep 18, 1987 | K872862 | PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS Serono Diagnostics, Inc. | CFT |
| Sep 14, 1987 | K873033 | HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE Serono Diagnostics, Inc. | JHI |
| Aug 5, 1987 | K872727 | LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE Serono Diagnostics, Inc. | CEP |
| Jul 31, 1987 | K872897 | TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA. Serono Diagnostics, Inc. | JLW |
| Jul 21, 1987 | K872627 | FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH Serono Diagnostics, Inc. | CGJ |
| Apr 29, 1987 | K870946 | MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST Serono Diagnostics, Inc. | LJP |
| Feb 19, 1987 | K864565 | MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT Serono Diagnostics, Inc. | GQH |
| Jan 7, 1987 | K864677 | TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP Serono Diagnostics, Inc. | JLW |
| Sep 16, 1986 | K862813 | FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT Serono Diagnostics, Inc. | CGJ |
| Jul 29, 1986 | K862262 | HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS Serono Diagnostics, Inc. | JHI |
| Jul 16, 1986 | K861379 | MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT Serono Diagnostics, Inc. | LKT |
| Jun 27, 1986 | K861361 | ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE Serono Diagnostics, Inc. | CHP |
| Jan 28, 1986 | K854615 | MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES Serono Diagnostics, Inc. | LKI |
| Oct 11, 1984 | K842966 | RENIN RADIOIMMUNOASSAY TEST KIT Serono Diagnostics, Inc. | CIB |
| Oct 11, 1984 | K842965 | GASTRIN RADIOIMMUNOASSAY TEST KIT Serono Diagnostics, Inc. | |
| Apr 13, 1984 | K833396 | C-PEPTIDE RADIOIMMUNOASSAY TEST KIT Serono Diagnostics, Inc. | JKD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||