Medical Device Manufacturer · US , San Luis Obispo , CA

U. S. Diagnostics, Inc. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 1986

Total

Cleared

Denied

U. S. Diagnostics, Inc. has 22 FDA 510(k) cleared medical devices. Based in San Luis Obispo, US.

Historical record: 22 cleared submissions from 1986 to 2011. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by U. S. Diagnostics, Inc. Filter by specialty or product code using the sidebar.

U. S. Diagnostics, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - U. S. Diagnostics, Inc.

22 devices

1-22 of 22

Cleared Sep 21, 2011

EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM

K110435 · NBW

Chemistry · 218d

Cleared Feb 20, 2009

G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A

K082201 · NBW

Chemistry · 199d

Cleared Jan 12, 2007

EASYGLUCO, MODEL IGM-0002 G2

PROTHROMBIN TIME TEST

K870596 · GJS

Hematology · 69d

Cleared Apr 20, 1987

COAGULATION CONTROL, LEVEL I

K870685 · JPA

Hematology · 60d

Cleared Apr 20, 1987

COAGULATION CONTROL, LEVEL II

K870686 · JPA

Hematology · 60d

Cleared Apr 20, 1987

COAGULATION CONTROL, LEVEL III

K870687 · JPA

Hematology · 60d

Cleared Apr 15, 1987

CYANMETHEMOGLOBIN STANDARD

K871283 · KRZ

Hematology · 15d

Cleared Apr 13, 1987

U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL

K870737 · JJT

Chemistry · 47d

Cleared Apr 13, 1987

U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL

K870738 · JJT

Chemistry · 47d

Cleared Apr 06, 1987

LIQUID CHEMISTRY CONTROL, LEVEL II

K870683 · JJY

Chemistry · 46d

Cleared Apr 06, 1987

LIQUID CHEMISTRY CONTROL, LEVEL I

K870684 · JJY

Chemistry · 46d

Cleared Mar 31, 1987

O.O2 M CALCIUM CHLORIDE SOLUTION

K870688 · JPA

Hematology · 40d

Cleared Dec 04, 1986

U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST

K863980 · CJE

Chemistry · 51d

Cleared Dec 04, 1986

U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST

K864081 · CHH

Chemistry · 45d

Cleared Dec 04, 1986

U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST

ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST

K862669 · GFD

General & Plastic Surgery · 81d

Cleared Sep 03, 1986

ENZYMATIC BLOOD GLUCOSE

K862721 · CGA

Chemistry · 48d

Cleared Aug 21, 1986

U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)

K862641 · KHG

Hematology · 41d

U. S. Diagnostics, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - U. S. Diagnostics, Inc.

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