Diagnostic Solutions, Inc.
Mchenry, IL, US
Diagnostic Solutions, Inc. appears in FDA device records in Mchenry, IL. FDA records list 26 510(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
- 26
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 26 510(k) clearances for Diagnostic Solutions, Inc. between 1980 and 1994. The busiest year on record is 1980, with 23. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 23 |
| 1992 | 2 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K934892 | RELIEF PLUS ONE REAGENT STRIP MODIFICATION | CGA | Substantially Equivalent | |
| K924398 | UNI-CHECK REAGENT STRIP | CGA | Substantially Equivalent | |
| K921825 | QUICK-CHECK II REAGENT STRIP | CGA | Substantially Equivalent | |
| K800689 | REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- | CKA | Substantially Equivalent | |
| K800681 | REAGENTS FOR DETERM. CO2 IN HUMAN SERUM | KMS | Substantially Equivalent | |
| K800692 | REAGENT FOR DETERM. POTASSIUM/IN HUMAN | CEM | Substantially Equivalent | |
| K800691 | REAGENT FOR DETERM. LACTATE/DEHYDROGENAS | CFJ | Substantially Equivalent | |
| K800690 | REAGENT FOR DETERM. INORGANIC/PHOSPHORUS | CEO | Substantially Equivalent | |
| K800688 | REAGENT FOR DETERM. GLUTAMIC-OXALOACETIC | CIT | Substantially Equivalent | |
| K800687 | REAGENT FOR DETERM. GLUCOSE IN H/SERUM | CGA | Substantially Equivalent | |
| K800686 | REAGENT FOR DETERM. DIRECT BILIRUBIN | CIG | Substantially Equivalent | |
| K800685 | REAGENT FOR DETERM. CREATININE IN H/SERU | CGX | Substantially Equivalent | |
| K800684 | REAGENT FOR DETERM. CREATINE PHOSPHOKINA | JHY | Substantially Equivalent | |
| K800683 | REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM | CHJ | Substantially Equivalent | |
| K800682 | REAGENTS FOR DETERM. CHOLESTEROL/SERUM | CGO | Substantially Equivalent | |
| K800680 | REAGENTS FOR DETERM. CALCIUM IN HUMAN | CIC | Substantially Equivalent | |
| K800679 | REAGENTS FOR DETERM. ALKALINE PHOSPHATAS | CJE | Substantially Equivalent | |
| K800678 | REAGENTS FOR DETERM. ALBUMIN IN HUMAN | CIX | Substantially Equivalent | |
| K800677 | REAGENTS FOR DETERM. SERUM IRON IN HUMAN | JIY | Substantially Equivalent | |
| K800676 | REAGENTS FOR DETERM. SODIUM IN HUMAN SUM | JGS | Substantially Equivalent | |
| K800675 | REAGENTS FOR DETERM. TOTAL BILIRUBIN | CIG | Substantially Equivalent | |
| K800674 | SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER | CEK | Substantially Equivalent | |
| K800673 | SMAC REPLACEMENT REAGENTS/OF BUN-SERUM | CDW | Substantially Equivalent | |
| K800672 | SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC | CDH | Substantially Equivalent | |
| K800671 | SMAC REPLACEMENT REAGENTS-WASH SOLUTIONS | Substantially Equivalent | ||
| K800670 | SMAC REPLACEMENT REAGENTS, WETTING AGENT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CDHAcid, Uric, Phosphotungstate Reduction
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- JHYColorimetric Method, Cpk Or Isoenzymes
- CICCresolphthalein Complexone, Calcium
- CDWDiacetyl-Monoxime, Urea Nitrogen
- CIGDiazo Colorimetry, Bilirubin
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGAGlucose Oxidase, Glucose
- CGOLieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- KMSPhenolphthalein Colorimetry, Carbon-Dioxide
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
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 Diagnostic Solutions, 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 Diagnostic Solutions, 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