U. S. Diagnostics, Inc.
New York, NY, US
U. S. Diagnostics, Inc. appears in FDA device records in New York, NY. FDA records list 22 510(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
- 22
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for U. S. Diagnostics, Inc. between 1986 and 2011. The busiest year on record is 1987, with 10. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 8 |
| 1987 | 10 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K110435 | EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K082201 | G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A | NBW | Substantially Equivalent | |
| K061431 | EASYGLUCO, MODEL IGM-0002 G2 | CGA | Substantially Equivalent | |
| K051651 | G4, MODEL IGM-0004 | NBW | Substantially Equivalent | |
| K870687 | COAGULATION CONTROL, LEVEL III | JPA | Substantially Equivalent | |
| K870686 | COAGULATION CONTROL, LEVEL II | JPA | Substantially Equivalent | |
| K870685 | COAGULATION CONTROL, LEVEL I | JPA | Substantially Equivalent | |
| K870596 | PROTHROMBIN TIME TEST | GJS | Substantially Equivalent | |
| K871283 | CYANMETHEMOGLOBIN STANDARD | KRZ | Substantially Equivalent | |
| K870738 | U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL | JJT | Substantially Equivalent | |
| K870737 | U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL | JJT | Substantially Equivalent | |
| K870684 | LIQUID CHEMISTRY CONTROL, LEVEL I | JJY | Substantially Equivalent | |
| K870683 | LIQUID CHEMISTRY CONTROL, LEVEL II | JJY | Substantially Equivalent | |
| K870688 | O.O2 M CALCIUM CHLORIDE SOLUTION | JPA | Substantially Equivalent | |
| K864231 | U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST | CDT | Substantially Equivalent | |
| K864081 | U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST | CHH | Substantially Equivalent | |
| K863980 | U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST | CJE | Substantially Equivalent | |
| K863889 | UREA NITROGEN TEST | CDL | Substantially Equivalent | |
| K864119 | URIC ACID TEST | KNK | Substantially Equivalent | |
| K862669 | ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST | GFD | Substantially Equivalent | |
| K862721 | ENZYMATIC BLOOD GLUCOSE | CGA | Substantially Equivalent | |
| K862641 | U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) | KHG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- CDLBerthelot Indophenol, Urea Nitrogen
- KRZCalibrator For Hemoglobin And Hematocrit Measurement
- GFDDermatome
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JJTEnzyme Controls (Assayed And Unassayed)
- CGAGlucose Oxidase, Glucose
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- NBWSystem, Test, Blood Glucose, Over The Counter
- GJSTest, Time, Prothrombin
- KHGWhole Blood Hemoglobin Determination
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 U. S. 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 U. S. 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