Syn-Kit, Inc.
Medical device manufacturer in Chatsworth, CA.
34510(k) clearances
0PMA approvals
0recalls
Device types
- JIL Method, Enzymatic, Glucose (Urinary… 11
- DHR System, Test, Rheumatoid Factor 2
- DCN System, Test, C-Reactive Protein 2
- KHE Reagent, Occult Blood 2
- GHH Fibrin Split Products 1
- GTZ Antisera, All Groups, Streptococcus Spp. 1
- JXA Kit, Screening, Urine 1
- GTQ Antistreptolysin - Titer/Streptolysin O… 1
- JJB Azo-Dyes, Colorimetric, Bilirubin & Its… 1
- CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) 1
- CDO Acid, Uric, Uricase (U.V.) 1
- JGY Colorimetric Method, Triglycerides 1
- CHH Enzymatic Esterase--Oxidase, Cholesterol 1
- GMQ Antigens, Nontreponemal, All 1
- JSS Kit, Identification, Enterobacteriaceae 1
- JHJ Agglutination Method, Human Chorionic… 1
- LBS Ldl & Vldl Precipitation, Cholesterol Via… 1
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 1
- JHQ Nephelometric Method, Lipoproteins 1
- GMM Antigens, Iha, Toxoplasma Gondii 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K861098 | Seroiden Strepto Kit 'Eiken'GTZ · Traditional | 08/12/1986SE |
| K861631 | Slide Culture U 'Eiken'JXA · Traditional | 06/10/1986SE |
| K854819 | CPR Slide EikenDCN · Traditional | 02/26/1986SE |
| K854820 | Ra 80 EikenDHR · Traditional | 01/17/1986SE |
| K853276 | Aso Slide EikenGTQ · Traditional | 08/20/1985SE |
| K843760 | Uropaper Eiken GJIL · Traditional | 12/18/1984SE |
| K843759 | Uropaper Eiken HagJIL · Traditional | 12/18/1984SE |
| K843758 | Uropaper Eiken GKJIL · Traditional | 12/18/1984SE |
| K843757 | Uropaper Eiken AGJIL · Traditional | 12/18/1984SE |
| K843756 | Uropaper Eiken 5JIL · Traditional | 12/18/1984SE |
| K843755 | Uropaper Eiken 6BJIL · Traditional | 12/18/1984SE |
| K843754 | Uropaper Eiken 7JIL · Traditional | 12/18/1984SE |
| K843753 | Uropaper Eiken GPJIL · Traditional | 12/18/1984SE |
| K843532 | Uropaper Eiken 8KHE · Traditional | 12/12/1984SE |
| K833521 | Reagent Tests Strip CombinationsJJB · Traditional | 01/11/1984SE |
| K830824 | Urine Screening KitCEN · Traditional | 06/12/1983SE |
| K821167 | Uricase (U.V.) Uric AcidCDO · Traditional | 05/14/1982SE |
| K821106 | Triglyzyme V EikenJGY · Traditional | 05/05/1982SE |
| K821105 | Cholestezyme-V EikenCHH · Traditional | 05/05/1982SE |
| K820567 | Trep Card EikenGMQ · Traditional | 04/14/1982SE |
| K813164 | Systek #1 EikenJSS · Traditional | 12/31/1981SE |
| K812298 | Fibrogen(Fibrin Split Product) AntigenGHH · Traditional | 12/17/1981SE |
| K811815 | Uropaper EikegKHE · Traditional | 12/10/1981SE |
| K811816 | Uropaper Eiken UhagJIL · Traditional | 12/08/1981SE |
| K813192 | Hdl-C EikenLBS · Traditional | 11/27/1981SE |
| K811818 | Uropaper Eiken UagJIL · Traditional | 07/23/1981SE |
| K811817 | Uropaper Eiken AGJIL · Traditional | 07/15/1981SE |
| K802447 | Got Isoenzyme Assay Eiken KitCIT · Traditional | 04/17/1981SE |
| K810862 | CRP SlideDCN · Traditional | 04/08/1981SE |
| K802451 | BLF Eiken Kit Deter. of B-Lipopr. Frac.JHQ · Traditional | 01/09/1981SE |
| K802448 | Ra 80 Eiken Kit Determ. of Rheumatic F.DHR · Traditional | 01/05/1981SE |
| K802452 | Toxotest-Mt Eiken KitGMM · Traditional | 12/18/1980SE |
| K802454 | Geste Follow Kit Determ. of HPLJMF · Traditional | 11/12/1980SE |
| K802450 | Gestate Slide Eiken Kit Agg. Method HumJHJ · Traditional | 10/31/1980SE |