Medical Device Manufacturer · US , Walker , MI

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

11 submissions · 11 cleared · Since 1984

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Kyoto Diagnostics, Inc. Chemistry ✕

8 devices

1-8 of 8

Cleared Jul 25, 1986

ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS

Chemistry · 80d

Cleared Aug 17, 1984

OSMOTIC PRESSURE AUTO & STAT OM-6010

Chemistry · 35d

Cleared Jul 16, 1984

ATAGO URINE SPECIFIC GRAVITY & SERUM

Chemistry · 46d

Cleared May 31, 1984

KYOTEST UG URINE TEST REAGENT STRIP

Chemistry · 37d

Cleared May 31, 1984

KYOTEST 2V, URINE TEST REAGENT STRIP

Chemistry · 37d

Cleared May 31, 1984

KYOTEST UK URINE TEST REAGENT STRIP

Chemistry · 37d

Cleared May 14, 1984

Chemistry · 80d

Cleared May 01, 1984

URINE ANALYZER SYSTEM

Chemistry · 54d