Diagnostic Specialties
Medical device manufacturer in Metuchen, NJ.
8510(k) clearances
0PMA approvals
0recalls
Device types
- CGA Glucose Oxidase, Glucose 1
- CEJ Tetraphenyl Borate, Colorimetry, Potassium 1
- LCX Kit, Test, Pregnancy, Hcg, Over The Counter 1
- JHJ Agglutination Method, Human Chorionic… 1
- JIR Indicator Method, Protein Or Albumin… 1
- LCP Assay, Glycosylated Hemoglobin 1
- GIS Test, Fibrinogen 1
- JIQ Turbidimetric Method, Protein Or Albumin… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K971458 | Enzip Immunoturbidimetric Microalbumin Assay KitJIQ · Traditional | 09/02/1997SE |
| K941001 | Enzip Immunoturbidmetric Fibrinogen Assay KitGIS · Traditional | 08/30/1994SE |
| K930823 | Protein-Bound Glucose Assayn KitLCP · Traditional | 08/19/1993SE |
| K922032 | Enzip Urinary Microalbumin TestJIR · Traditional | 07/30/1992SE |
| K831180 | Pregna-Cert, Slide Pregnancy TestJHJ · Traditional | 05/27/1983SE |
| K823109 | Generic Pregnancy TestLCX · Traditional | 11/10/1982SE |
| K813608 | Potassium Reagent SetCEJ · Traditional | 01/22/1982SE |
| K813412 | Glucose Enzyme-Color Reagent SetCGA · Traditional | 12/31/1981SE |