Diagnostic Technology, Inc.
Medical device manufacturer in Hauppauge, NY.
28510(k) clearances
0PMA approvals
0recalls
Device types
- GKL Counter, Cell, Automated (Particle Counter) 5
- JPK Mixture, Hematology Quality Control 3
- JHJ Agglutination Method, Human Chorionic… 3
- GNP Antiserum, Cf, Epstein-Barr Virus 2
- LSR Reagent, Borrelia Serological Reagent 1
- KSF Kit, Quality Control For Blood Banking… 1
- LSE Epstein-Barr Virus, Other 1
- LLM Test, Antigen, Nuclear, Epstein-Barr Virus 1
- HIS Condom 1
- LJN Antibody Igm, If, Epstein-Barr Virus 1
- LJP Antiserum, Fluorescent, Chlamydia Trachomatis 1
- KTN System, Test, Infectious Mononucleosis 1
- GTQ Antistreptolysin - Titer/Streptolysin O… 1
- DHR System, Test, Rheumatoid Factor 1
- DCN System, Test, C-Reactive Protein 1
- LKJ Antinuclear Antibody, Antigen, Control 1
- JCM Control, Hemoglobin, Abnormal 1
- KRX Calibrator For Cell Indices 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K896378 | Lyme-Check(Tm) Test KitLSR · Traditional | 11/05/1991SE |
| K903612 | Ebv/Ea-Check TM Test KitLSE · Traditional | 10/16/1990SE |
| K891542 | Ebna-Check(Tm) Test KitLLM · Traditional | 06/20/1989SE |
| K890819 | Hsv-Check(Tm) Test KitHIS · Traditional | 06/20/1989SE |
| K890639 | Resubmitted Ebv/Igm-Check Test KitLJN · Traditional | 06/20/1989SE |
| K871373 | Ebv-Check(Tm) Test Kit (Igg)GNP · Traditional | 06/25/1987SE |
| K864128 | Chlamydia-Check(Tm) Direct & Culture Confir. KitLJP · Traditional | 04/29/1987SE |
| K863408 | Ebv/Vca-Check(Tm) Antigen SlidesGNP · Traditional | 11/28/1986SE |
| K860586 | PHA-2 Conversion Program for Platelet AnalysisGKL · Traditional | 05/07/1986SE |
| K860166 | Picoscale Blood Cell Counter, Model PS-5GKL · Traditional | 04/04/1986SE |
| K853036 | Picoscale Laborscale, #PSL-1 & Analyser, #PSA-1GKL · Traditional | 11/05/1985SE |
| K841809 | Count-A-Part PlusJPK · Traditional | 11/30/1984SE |
| K842140 | Picoscal Blood Cell Counter PS-4GKL · Traditional | 08/16/1984SE |
| K834372 | PHA-1 Programmable Hematology AnalyzGKL · Traditional | 02/10/1984SE |
| K834345 | Im-CheckKTN · Traditional | 02/10/1984SE |
| K834346 | Bhcg-CheckJHJ · Traditional | 02/04/1984SE |
| K831468 | B Hcg-CheckJHJ · Traditional | 06/22/1983SE |
| K831466 | Hcg-CheckJHJ · Traditional | 06/22/1983SE |
| K831464 | Aso-CheckGTQ · Traditional | 06/16/1983SE |
| K831467 | Ra-CheckDHR · Traditional | 06/08/1983SE |
| K831465 | Crp-CheckDCN · Traditional | 06/08/1983SE |
| K831463 | Ana-CheckLKJ · Traditional | 06/08/1983SE |
| K827289 | Digital Radiography System · Traditional | 04/21/1982SE |
| K820037 | Sickle-CheckJCM · Traditional | 02/04/1982SE |
| K811063 | Laser-CalKRX · Traditional | 07/01/1981SE |
| K791772 | Counter-Check Plus Normal, High Abn.JPK · Traditional | 10/11/1979SE |
| K791750 | Counter-Check PlusJPK · Traditional | 10/11/1979SE |
| K790025 | Counter Check, H001, H002, H003KSF · Traditional | 01/17/1979SE |