Smithkline Diagnostics, Inc.
Medical device manufacturer in Sharon Hill, PA.
42510(k) clearances
0PMA approvals
0recalls
Device types
- IYO System, Imaging, Pulsed Echo, Ultrasonic 5
- KHE Reagent, Occult Blood 4
- JHS Differential Rate Kinetic Method, Cpk Or… 4
- CFJ Nad Reduction/Nadh Oxidation, Lactate… 3
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 2
- CFR Hexokinase, Glucose 2
- LYR Helicobacter Pylori 2
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 2
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 2
- CHH Enzymatic Esterase--Oxidase, Cholesterol 2
- HGM System, Monitoring, Perinatal 1
- DND Radioimmunoassay, Digitoxin (125-I), Rabbit… 1
- HHK Curette, Suction, Endometrial (And… 1
- HEM Imager, Ultrasonic Obstetric-Gynecologic 1
- CDP Radioimmunoassay, Total Triiodothyronine 1
- JFH Acid Phosphatase (Prostatic), Tartrate… 1
- CDO Acid, Uric, Uricase (U.V.) 1
- DXK Echocardiograph 1
- JJT Enzyme Controls (Assayed And Unassayed) 1
- JIY Photometric Method, Iron (Non-Heme) 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K961062 | Flexsure ObtKHE · Traditional | 11/06/1996SE |
| K960183 | Flexsure Hp,Controls for Flexsurehp,Flexpack Hp(Abbott Diagnostics)Andcontrols for…LYR · Traditional | 06/07/1996SE |
| K934863 | Flexsure HPLYR · Traditional | 05/18/1994SE |
| K880499 | Hemoccult Sensitive TestKHE · Traditional | 05/23/1988SE |
| K875131 | (SKD) Cholesterol Test KitCHH · Traditional | 03/01/1988SE |
| K862849 | Hemoccult Wipe TestKHE · Traditional | 12/09/1986SE |
| K854723 | SKD Electrochemical System (Ecs)CEM · Traditional | 03/05/1986SE |
| K852841 | Rapid Direct Strep a Latex Agglutination TestGTZ · Traditional | 07/24/1985SE |
| K821884 | Gastroccult TMKHE · Traditional | 10/08/1982SE |
| K821674 | Spinchem Acid Phosphatase ReagentCKB · Traditional | 06/22/1982SE |
| K821184 | Spin Chem Reagents & StandardsJIY · Traditional | 05/24/1982SE |
| K821183 | Target Isocheck Control SerumJJT · Traditional | 05/14/1982SE |
| K812646 | Ski 5000DXK · Traditional | 11/16/1981SE |
| K812472 | Spin-Chem Ld-L ReagentCFJ · Traditional | 09/14/1981SE |
| K812471 | Spin-Chem Triglycerides ReagentCDT · Traditional | 09/14/1981SE |
| K811850 | Eskaflow Test for TriglyceridesCDT · Traditional | 07/23/1981SE |
| K811849 | Eskaflow Test for GlucoseCFR · Traditional | 07/15/1981SE |
| K810914 | 5CM Small Parts ScannerIYO · Traditional | 05/08/1981SE |
| K803234 | Eskachem Pap ReagentJFH · Traditional | 02/26/1981SE |
| K801060 | High Resolution 10CM Diag. Ultra. ScanneIYO · Traditional | 06/04/1980SE |
| K800824 | Model SKI-200 Abdominal ScannerIYO · Traditional | 05/14/1980SE |
| K800532 | S.K. Diag. Ultrasound Body ScannerIYO · Traditional | 04/10/1980SE |
| K800531 | S.K. Diag. Ultrasnd. Small Parts ScanIYO · Traditional | 04/10/1980SE |
| K792023 | Eskachem, Ck-Mb ReagentJHS · Traditional | 10/30/1979SE |
| K791080 | Plus Chem S.C.E. ReagentCIT · Traditional | 07/24/1979SE |
| K791085 | Plus Chem, Determination of LD (Ldh-P)CFJ · Traditional | 07/17/1979SE |
| K791084 | Plus Chem, Determination of Alt (GPT)CKA · Traditional | 07/17/1979SE |
| K791083 | Spin Chem, Determination of Alt (GPT)CKA · Traditional | 07/17/1979SE |
| K791082 | Spin Chem Reagent, Determination of AstCIT · Traditional | 07/17/1979SE |
| K791081 | Spin Chem Reagent, Determination of Ldh-CFJ · Traditional | 07/17/1979SE |
| K790918 | Esklab Reagent TabletsJHS · Traditional | 06/22/1979SE |
| K790917 | Spin Chem Ck-Nac ReagentJHS · Traditional | 06/22/1979SE |
| K790916 | Ck-Nuc ReagentJHS · Traditional | 06/22/1979SE |
| K772121 | Aspirator & Probe, Cytology, Endomet.HHK · Traditional | 11/17/1977SE |
| K770767 | In Vitro Diag. for Uric AcidCDO · Traditional | 07/05/1977SE |
| K770483 | Cholesterol ReagentCHH · Traditional | 06/08/1977SE |
| K761180 | Sigmoidoscope/ DisposableFAM · Traditional | 01/05/1977SE |
| K761052 | Real Time Obstetrical Ultrasonic ScannerHEM · Traditional | 12/16/1976SE |
| K761030 | Ekosector IHGM · Traditional | 12/13/1976SE |
| K760057 | Test, Ria, TriodothyronineCDP · Traditional | 09/13/1976SE |
| K760055 | Reagent, Glucose, Flow-Through AnalyzerCFR · Traditional | 08/26/1976SE |
| K760077 | Test, Ria, Serum DigoxinDND · Traditional | 07/16/1976SE |