Crestat Diagnostics, Inc.
Medical device manufacturer in Seattle, WA.
29510(k) clearances
0PMA approvals
0recalls
Device types
- CFN Method, Nephelometric, Immunoglobulins (G… 3
- DER Alpha-1-Lipoprotein, Antigen, Antiserum… 3
- CIG Diazo Colorimetry, Bilirubin 2
- DCK C-Reactive Protein, Antigen, Antiserum, And… 2
- DBI Complement C4, Antigen, Antiserum, Control 2
- CZW Complement C3, Antigen, Antiserum, Control 1
- CFR Hexokinase, Glucose 1
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 1
- DDQ Antigen, Antiserum, Control, Antithrombin Iii 1
- GGP Test, Qualitative And Quantitative Factor… 1
- DEM Alpha-1-Antitrypsin, Antigen, Antiserum… 1
- DBA Complement C1 Inhibitor (Inactivator)… 1
- DAD Haptoglobin, Antigen, Antiserum, Control 1
- LKL Alpha-1-Acid-Glycoprotein, Antigen… 1
- CKB Acid Phosphatase, Naphthyl Phosphate 1
- DDG Transferrin, Antigen, Antiserum, Control 1
- KQJ System, Fibrinogen Determination 1
- CFF Immunoelectrophoretic, Immunoglobulins, (G… 1
- JIR Indicator Method, Protein Or Albumin… 1
- JIX Calibrator, Multi-Analyte Mixture 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K980883 | N-Assay Glu-UlCFR · Traditional | 09/03/1998SE |
| K981276 | N-Assay L D-BilCIG · Traditional | 05/01/1998SE |
| K981289 | N-Assay L T-BilCIG · Traditional | 04/27/1998SE |
| K980902 | N-Assay L Ast/GotCIT · Traditional | 03/26/1998SE |
| K980900 | N-Assay Cpk-LCGS · Traditional | 03/26/1998SE |
| K972257 | N-Assay Tia Antithrombin III Test KitDDQ · Traditional | 10/20/1997SE |
| K971985 | N-Assay Tia Plasminogen Test KitGGP · Traditional | 10/20/1997SE |
| K964296 | N-Assay Tia Apo B Test KitDER · Traditional | 08/01/1997SE |
| K964294 | N-Assay Tia Apo A1/B Multi CalibratorDER · Traditional | 08/01/1997SE |
| K964292 | N-Assay Tia Apo A1 Test KitDER · Traditional | 08/01/1997SE |
| K965100 | N-Assay Tia ALPHA-1-ANTITRYPSIN Test KitDEM · Traditional | 07/14/1997SE |
| K965024 | N-Assay Tia C1-INACTIVATOR Test KitDBA · Traditional | 07/14/1997SE |
| K964301 | N-Assay Tia Multi V-NlDAD · Traditional | 07/14/1997SE |
| K964300 | N-Assay Tia Multi V-NlDBI · Traditional | 07/14/1997SE |
| K964299 | N-Assay Tia Multi V-NlLKL · Traditional | 07/14/1997SE |
| K964298 | N-Assay Tia Multi V-NlCZW · Traditional | 07/14/1997SE |
| K964297 | N-Assay Tia C4 Test KitDBI · Traditional | 07/14/1997SE |
| K965110 | N-Assay Tia Multi CRP Calibrator SetDCK · Traditional | 07/03/1997SE |
| K964295 | N-Assay Tia Transferrin Test KitDDG · Traditional | 06/16/1997SE |
| K965113 | N-Assay Tia Fibrinogen Test KitKQJ · Traditional | 04/16/1997SE |
| K933972 | N-Assay Tia IggCFF · Traditional | 03/22/1994SE |
| K933971 | N-Assay Tia IgaCFN · Traditional | 03/22/1994SE |
| K933970 | N-Assay Tia IgmCFN · Traditional | 03/22/1994SE |
| K933973 | N-Assay Tia Multi V-NlCFN · Traditional | 01/28/1994SE |
| K934146 | N-Assay Tia MicroalbuminJIR · Traditional | 01/11/1994SE |
| K934143 | N-Assay Tia Microalbumin Calibrator SetJIX · Traditional | 11/05/1993SE |
| K914155 | Tia CRP Test KitDCK · Traditional | 01/15/1992SE |
| K912148 | Cholinesterase Test KitDIH · Traditional | 08/12/1991SE |
| K902543 | Acid Phosphotase Reagent Test and KitCKB · Traditional | 09/07/1990SE |