Smithkline Diagnostics, Inc.
Mchenry, IL, US
Smithkline Diagnostics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 42 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 42
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 42 510(k) clearances for Smithkline Diagnostics, Inc. between 1976 and 1996. The busiest year on record is 1979, with 10. The most recent is 1996, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 5 |
| 1977 | 4 |
| 1979 | 10 |
| 1980 | 4 |
| 1981 | 7 |
| 1982 | 4 |
| 1985 | 1 |
| 1986 | 2 |
| 1988 | 2 |
| 1994 | 1 |
| 1996 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K961062 | FLEXSURE OBT | KHE | Substantially Equivalent | |
| K960183 | FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS) | LYR | Substantially Equivalent | |
| K934863 | FLEXSURE HP | LYR | Substantially Equivalent | |
| K880499 | HEMOCCULT SENSITIVE TEST | KHE | Substantially Equivalent | |
| K875131 | (SKD) CHOLESTEROL TEST KIT | CHH | Substantially Equivalent | |
| K862849 | HEMOCCULT WIPE TEST | KHE | Substantially Equivalent | |
| K854723 | SKD ELECTROCHEMICAL SYSTEM (ECS) | CEM | Substantially Equivalent | |
| K852841 | RAPID DIRECT STREP A LATEX AGGLUTINATION TEST | GTZ | Substantially Equivalent | |
| K821884 | GASTROCCULT TM | KHE | Substantially Equivalent | |
| K821674 | SPINCHEM ACID PHOSPHATASE REAGENT | CKB | Substantially Equivalent | |
| K821184 | SPIN CHEM REAGENTS & STANDARDS | JIY | Substantially Equivalent | |
| K821183 | TARGET ISOCHECK CONTROL SERUM | JJT | Substantially Equivalent | |
| K812646 | SKI 5000 | DXK | Substantially Equivalent | |
| K812472 | SPIN-CHEM LD-L REAGENT | CFJ | Substantially Equivalent | |
| K812471 | SPIN-CHEM TRIGLYCERIDES REAGENT | CDT | Substantially Equivalent | |
| K811850 | ESKAFLOW TEST FOR TRIGLYCERIDES | CDT | Substantially Equivalent | |
| K811849 | ESKAFLOW TEST FOR GLUCOSE | CFR | Substantially Equivalent | |
| K810914 | 5CM SMALL PARTS SCANNER | IYO | Substantially Equivalent | |
| K803234 | ESKACHEM PAP REAGENT | JFH | Substantially Equivalent | |
| K801060 | HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE | IYO | Substantially Equivalent | |
| K800824 | MODEL SKI-200 ABDOMINAL SCANNER | IYO | Substantially Equivalent | |
| K800532 | S.K. DIAG. ULTRASOUND BODY SCANNER | IYO | Substantially Equivalent | |
| K800531 | S.K. DIAG. ULTRASND. SMALL PARTS SCAN | IYO | Substantially Equivalent | |
| K792023 | ESKACHEM, CK-MB REAGENT | JHS | Substantially Equivalent | |
| K791080 | PLUS CHEM S.C.E. REAGENT | CIT | Substantially Equivalent | |
| K791085 | PLUS CHEM, DETERMINATION OF LD (LDH-P) | CFJ | Substantially Equivalent | |
| K791084 | PLUS CHEM, DETERMINATION OF ALT (GPT) | CKA | Substantially Equivalent | |
| K791083 | SPIN CHEM, DETERMINATION OF ALT (GPT) | CKA | Substantially Equivalent | |
| K791082 | SPIN CHEM REAGENT, DETERMINATION OF AST | CIT | Substantially Equivalent | |
| K791081 | SPIN CHEM REAGENT, DETERMINATION OF LDH- | CFJ | Substantially Equivalent | |
| K790918 | ESKLAB REAGENT TABLETS | JHS | Substantially Equivalent | |
| K790917 | SPIN CHEM CK-NAC REAGENT | JHS | Substantially Equivalent | |
| K790916 | CK-NUC REAGENT | JHS | Substantially Equivalent | |
| K772121 | ASPIRATOR & PROBE, CYTOLOGY, ENDOMET. | HHK | Substantially Equivalent | |
| K770767 | IN VITRO DIAG. FOR URIC ACID | CDO | Substantially Equivalent | |
| K770483 | CHOLESTEROL REAGENT | CHH | Substantially Equivalent | |
| K761180 | SIGMOIDOSCOPE/ DISPOSABLE | FAM | Substantially Equivalent | |
| K761052 | REAL TIME OBSTETRICAL ULTRASONIC SCANNER | HEM | Substantially Equivalent | |
| K761030 | EKOSECTOR I | HGM | Substantially Equivalent | |
| K760057 | TEST, RIA, TRIODOTHYRONINE | CDP | Substantially Equivalent | |
| K760055 | REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER | CFR | Substantially Equivalent | |
| K760077 | TEST, RIA, SERUM DIGOXIN | DND | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited
- CKBAcid Phosphatase, Naphthyl Phosphate
- CDOAcid, Uric, Uricase (U.V.)
- GTZAntisera, All Groups, Streptococcus Spp.
- HHKCurette, Suction, Endometrial (And Accessories)
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes
- DXKEchocardiograph
- CEMElectrode, Ion Specific, Potassium
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JJTEnzyme Controls (Assayed And Unassayed)
- LYRHelicobacter Pylori
- CFRHexokinase, Glucose
- HEMImager, Ultrasonic Obstetric-Gynecologic
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- JIYPhotometric Method, Iron (Non-Heme)
- DNDRadioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.
- CDPRadioimmunoassay, Total Triiodothyronine
- KHEReagent, Occult Blood
- FAMSigmoidoscope And Accessories, Flexible/Rigid
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- HGMSystem, Monitoring, Perinatal
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Smithkline Diagnostics, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Smithkline Diagnostics, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain