Medical Device Manufacturer · US , Ft. Lauderdale , FL

Tcpi, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1992

14

Total

14

Cleared

0

Denied

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

8 devices

1-8 of 8

Cleared Oct 07, 1998

HEALTH CHECK URI-TEST PROTEIN IN URINE

Chemistry · 422d

Cleared Jul 26, 1996

HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST

Chemistry · 273d

Cleared Jul 22, 1996

URITEST - NITRITE IN URINE TEST

Chemistry · 285d

Cleared Mar 19, 1996

ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT

Chemistry · 119d

Cleared Oct 20, 1994

HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE

Chemistry · 209d

Cleared Jan 11, 1994

ONE STEP LH TEST

Chemistry · 75d

Cleared Dec 02, 1993

HCG PREGNANCY ONE STEP TEST STRIP

Chemistry · 55d

Cleared Sep 09, 1992

HCG PREGNANCY ONE STEP TEST STRIP

Chemistry · 75d