Medical Device Manufacturer · US , Mountain View , CA

United Biotech, Inc. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 1985

22

Total

22

Cleared

0

Denied

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

10 devices

1-10 of 10

Cleared Sep 15, 1998

UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE

Chemistry · 134d

Cleared Jul 08, 1996

UBI MAGIWEL THYROXINE (T4) QUANTITATIVE

Chemistry · 28d

Cleared May 30, 1996

UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE

Chemistry · 62d

Cleared Jan 31, 1991

UBI MAGIWEL CORTISOL QUANTITATIVE

Chemistry · 56d

Cleared Mar 13, 1987

UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE

Chemistry · 140d

Cleared Feb 04, 1987

UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE

Chemistry · 152d

Cleared Dec 16, 1986

UBI MAGIWEL(TM) PROLACTIN QUANTATIVE

Chemistry · 57d

Cleared Dec 16, 1986

UBI MAGIWEL(TM) TSH QUANTITATIVE

Chemistry · 57d

Cleared Nov 13, 1986

UBI MAGIWEL(TM) FSH QUANTITATIVE

Chemistry · 24d

Cleared May 10, 1985

UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST

Chemistry · 53d