Medical Device Manufacturer · US , San Luis Obispo , CA

U. S. Diagnostics, Inc.

22 submissions · 22 cleared · Since 1986
22
Total
22
Cleared
0
Denied

U. S. Diagnostics, Inc. — FDA 510(k) Submissions

U. S. Diagnostics, Inc. has submitted 22 FDA 510(k) premarket notifications since 1986, of which 22 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Multipurpose For In Vitro Coagulation Studies, System, Test, Blood Glucose, Over The Counter, Multi-analyte Controls, All Kinds (assayed), Glucose Oxidase, Glucose, Enzyme Controls (assayed And Unassayed) . Use the specialty filter in the sidebar to narrow results.

22 devices
1–22 of 22
EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM
K110435 · NBW System, Test, Blood... · Chemistry
Sep 2011 218d
G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A
K082201 · NBW System, Test, Blood... · Chemistry
Feb 2009 199d
EASYGLUCO, MODEL IGM-0002 G2
K061431 · CGA Glucose Oxidase, Glucose · Chemistry
Jan 2007 233d
G4, MODEL IGM-0004
K051651 · NBW System, Test, Blood... · Chemistry
Apr 2006 297d
PROTHROMBIN TIME TEST
K870596 · GJS Test, Time, Prothrombin · Hematology
Apr 1987 69d
COAGULATION CONTROL, LEVEL I
K870685 · JPA System, Multipurpose For... · Hematology
Apr 1987 60d
COAGULATION CONTROL, LEVEL II
K870686 · JPA System, Multipurpose For... · Hematology
Apr 1987 60d
COAGULATION CONTROL, LEVEL III
K870687 · JPA System, Multipurpose For... · Hematology
Apr 1987 60d
CYANMETHEMOGLOBIN STANDARD
K871283 · KRZ Calibrator For Hemoglobin... · Hematology
Apr 1987 15d
U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL
K870737 · JJT Enzyme Controls (assayed... · Chemistry
Apr 1987 47d
U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL
K870738 · JJT Enzyme Controls (assayed... · Chemistry
Apr 1987 47d
LIQUID CHEMISTRY CONTROL, LEVEL II
K870683 · JJY Multi-analyte Controls,... · Chemistry
Apr 1987 46d
LIQUID CHEMISTRY CONTROL, LEVEL I
K870684 · JJY Multi-analyte Controls,... · Chemistry
Apr 1987 46d
O.O2 M CALCIUM CHLORIDE SOLUTION
K870688 · JPA System, Multipurpose For... · Hematology
Mar 1987 40d
U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST
K863980 · CJE Nitrophenylphosphate,... · Chemistry
Dec 1986 51d
U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST
K864081 · CHH Enzymatic... · Chemistry
Dec 1986 45d
U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST
K864231 · CDT Lipase... · Chemistry
Dec 1986 37d
UREA NITROGEN TEST
K863889 · CDL Berthelot Indophenol,... · Chemistry
Nov 1986 49d
URIC ACID TEST
K864119 · KNK Acid, Uric, Uricase... · Chemistry
Oct 1986 8d
ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K862669 · GFD Dermatome · General & Plastic Surgery
Oct 1986 81d
ENZYMATIC BLOOD GLUCOSE
K862721 · CGA Glucose Oxidase, Glucose · Chemistry
Sep 1986 48d
U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)
K862641 · KHG Whole Blood Hemoglobin... · Hematology
Aug 1986 41d
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