Company ยท US
Smithkline Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1996. Name variants (Inc, Corp, punctuation) are merged.
42510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 4 |
| KHE | Reagent, Occult Blood | 4 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 3 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 |
| CFR | Hexokinase, Glucose | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 2 |
| LYR | Helicobacter Pylori | 2 |
| CDO | Acid, Uric, Uricase (U.V.) | 1 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CEM | Electrode, Ion Specific, Potassium | 1 |
| CKB | Acid Phosphatase, Naphthyl Phosphate | 1 |
| DND | Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep. | 1 |
| DXK | Echocardiograph | 1 |
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 1 |
| HGM | System, Monitoring, Perinatal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 6, 1996 | K961062 | FLEXSURE OBT Smithkline Diagnostics, Inc. | KHE |
| Jun 7, 1996 | K960183 | FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS) Smithkline Diagnostics, Inc. | LYR |
| May 18, 1994 | K934863 | FLEXSURE HP Smithkline Diagnostics, Inc. | LYR |
| May 23, 1988 | K880499 | HEMOCCULT SENSITIVE TEST Smithkline Diagnostics, Inc. | KHE |
| Mar 1, 1988 | K875131 | (SKD) CHOLESTEROL TEST KIT Smithkline Diagnostics, Inc. | CHH |
| Dec 9, 1986 | K862849 | HEMOCCULT WIPE TEST Smithkline Diagnostics, Inc. | KHE |
| Mar 5, 1986 | K854723 | SKD ELECTROCHEMICAL SYSTEM (ECS) Smithkline Diagnostics, Inc. | CEM |
| Jul 24, 1985 | K852841 | RAPID DIRECT STREP A LATEX AGGLUTINATION TEST Smithkline Diagnostics, Inc. | GTZ |
| Oct 8, 1982 | K821884 | GASTROCCULT TM Smithkline Diagnostics, Inc. | KHE |
| Jun 22, 1982 | K821674 | SPINCHEM ACID PHOSPHATASE REAGENT Smithkline Diagnostics, Inc. | CKB |
| May 24, 1982 | K821184 | SPIN CHEM REAGENTS & STANDARDS Smithkline Diagnostics, Inc. | JIY |
| May 14, 1982 | K821183 | TARGET ISOCHECK CONTROL SERUM Smithkline Diagnostics, Inc. | JJT |
| Nov 16, 1981 | K812646 | SKI 5000 Smithkline Diagnostics, Inc. | DXK |
| Sep 14, 1981 | K812472 | SPIN-CHEM LD-L REAGENT Smithkline Diagnostics, Inc. | CFJ |
| Sep 14, 1981 | K812471 | SPIN-CHEM TRIGLYCERIDES REAGENT Smithkline Diagnostics, Inc. | CDT |
| Jul 23, 1981 | K811850 | ESKAFLOW TEST FOR TRIGLYCERIDES Smithkline Diagnostics, Inc. | CDT |
| Jul 15, 1981 | K811849 | ESKAFLOW TEST FOR GLUCOSE Smithkline Diagnostics, Inc. | CFR |
| May 8, 1981 | K810914 | 5CM SMALL PARTS SCANNER Smithkline Diagnostics, Inc. | IYO |
| Feb 26, 1981 | K803234 | ESKACHEM PAP REAGENT Smithkline Diagnostics, Inc. | JFH |
| Jun 4, 1980 | K801060 | HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE Smithkline Diagnostics, Inc. | IYO |
| May 14, 1980 | K800824 | MODEL SKI-200 ABDOMINAL SCANNER Smithkline Diagnostics, Inc. | IYO |
| Apr 10, 1980 | K800532 | S.K. DIAG. ULTRASOUND BODY SCANNER Smithkline Diagnostics, Inc. | IYO |
| Apr 10, 1980 | K800531 | S.K. DIAG. ULTRASND. SMALL PARTS SCAN Smithkline Diagnostics, Inc. | IYO |
| Oct 30, 1979 | K792023 | ESKACHEM, CK-MB REAGENT Smithkline Diagnostics, Inc. | JHS |
| Jul 24, 1979 | K791080 | PLUS CHEM S.C.E. REAGENT Smithkline Diagnostics, Inc. | CIT |
| Jul 17, 1979 | K791085 | PLUS CHEM, DETERMINATION OF LD (LDH-P) Smithkline Diagnostics, Inc. | CFJ |
| Jul 17, 1979 | K791084 | PLUS CHEM, DETERMINATION OF ALT (GPT) Smithkline Diagnostics, Inc. | CKA |
| Jul 17, 1979 | K791083 | SPIN CHEM, DETERMINATION OF ALT (GPT) Smithkline Diagnostics, Inc. | CKA |
| Jul 17, 1979 | K791082 | SPIN CHEM REAGENT, DETERMINATION OF AST Smithkline Diagnostics, Inc. | CIT |
| Jul 17, 1979 | K791081 | SPIN CHEM REAGENT, DETERMINATION OF LDH- Smithkline Diagnostics, Inc. | CFJ |
| Jun 22, 1979 | K790918 | ESKLAB REAGENT TABLETS Smithkline Diagnostics, Inc. | JHS |
| Jun 22, 1979 | K790917 | SPIN CHEM CK-NAC REAGENT Smithkline Diagnostics, Inc. | JHS |
| Jun 22, 1979 | K790916 | CK-NUC REAGENT Smithkline Diagnostics, Inc. | JHS |
| Nov 17, 1977 | K772121 | ASPIRATOR & PROBE, CYTOLOGY, ENDOMET. Smithkline Diagnostics, Inc. | HHK |
| Jul 5, 1977 | K770767 | IN VITRO DIAG. FOR URIC ACID Smithkline Diagnostics, Inc. | CDO |
| Jun 8, 1977 | K770483 | CHOLESTEROL REAGENT Smithkline Diagnostics, Inc. | CHH |
| Jan 5, 1977 | K761180 | SIGMOIDOSCOPE/ DISPOSABLE Smithkline Diagnostics, Inc. | FAM |
| Dec 16, 1976 | K761052 | REAL TIME OBSTETRICAL ULTRASONIC SCANNER Smithkline Diagnostics, Inc. | HEM |
| Dec 13, 1976 | K761030 | EKOSECTOR I Smithkline Diagnostics, Inc. | HGM |
| Sep 13, 1976 | K760057 | TEST, RIA, TRIODOTHYRONINE Smithkline Diagnostics, Inc. | CDP |
| Aug 26, 1976 | K760055 | REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER Smithkline Diagnostics, Inc. | CFR |
| Jul 16, 1976 | K760077 | TEST, RIA, SERUM DIGOXIN Smithkline Diagnostics, Inc. | DND |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||