Serono Diagnostics, Inc.
Walker, MI, US
Serono Diagnostics, Inc. appears in FDA device records in Walker, MI. FDA records list 25 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 25
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 25 510(k) clearances for Serono Diagnostics, Inc. between 1984 and 1996. The busiest year on record is 1987, with 11. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 3 |
| 1986 | 5 |
| 1987 | 11 |
| 1988 | 4 |
| 1994 | 1 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K953598 | SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS | GKZ | Substantially Equivalent | |
| K942051 | SR1 DHEA-S ENZYME IMMUNOASSAY | JKC | Substantially Equivalent | |
| K883085 | T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS | KHQ | Substantially Equivalent | |
| K882340 | LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA | CEP | Substantially Equivalent | |
| K880388 | T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE | CDP | Substantially Equivalent | |
| K874866 | T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE | KLI | Substantially Equivalent | |
| K873431 | PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH | JLS | Substantially Equivalent | |
| K873186 | LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA | CEP | Substantially Equivalent | |
| K873400 | PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA | CFT | Substantially Equivalent | |
| K872862 | PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS | CFT | Substantially Equivalent | |
| K873033 | HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE | JHI | Substantially Equivalent | |
| K872727 | LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE | CEP | Substantially Equivalent | |
| K872897 | TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA. | JLW | Substantially Equivalent | |
| K872627 | FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH | CGJ | Substantially Equivalent | |
| K870946 | MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST | LJP | Substantially Equivalent | |
| K864565 | MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT | GQH | Substantially Equivalent | |
| K864677 | TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP | JLW | Substantially Equivalent | |
| K862813 | FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT | CGJ | Substantially Equivalent | |
| K862262 | HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS | JHI | Substantially Equivalent | |
| K861379 | MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT | LKT | Substantially Equivalent | |
| K861361 | ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE | CHP | Substantially Equivalent | |
| K854615 | MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES | LKI | Substantially Equivalent | |
| K842966 | RENIN RADIOIMMUNOASSAY TEST KIT | CIB | Substantially Equivalent | |
| K842965 | GASTRIN RADIOIMMUNOASSAY TEST KIT | Substantially Equivalent | ||
| K833396 | C-PEPTIDE RADIOIMMUNOASSAY TEST KIT | JKD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus
- LKIAntisera, Fluorescent, Chlamydia Spp.
- LJPAntiserum, Fluorescent, Chlamydia Trachomatis
- GKZCounter, Differential Cell
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- KHQRadioassay, Triiodothyronine Uptake
- CIBRadioimmunoassay, Angiotensin I And Renin
- JKDRadioimmunoassay, C-Peptides Of Proinsulin
- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDPRadioimmunoassay, Total Triiodothyronine
- LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain