Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

United Biotech, Inc. — Predicate Candidate Screening

22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

67 daysmedian FDA review time
228 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K981573UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVEUnited Biotech, Inc.1998-09-151340
K973154UBI MAGIWEL MARIJUANA METABOLITESUnited Biotech, Inc.1998-07-223340
K973692UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVEUnited Biotech, Inc.1998-02-091360
K973155UBI MAGIWEL OPIATE METABOLITESUnited Biotech, Inc.1997-10-28670
K973156UBI MAGIWEL COCAINE METABOLITESUnited Biotech, Inc.1997-10-28670
K973153UBI MAGIWEL AMPHETAMINE METABOLITESUnited Biotech, Inc.1997-10-28670
K962211UBI MAGIWEL THYROXINE (T4) QUANTITATIVEUnited Biotech, Inc.1996-07-08280
K961236UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVEUnited Biotech, Inc.1996-05-30620
K951993UBI MAGIWEL FERRITIN QUANTITATIVEUnited Biotech, Inc.1995-07-05680
K924689UBI MAGIWEL(TM) HELICOBACTER PYLORI IGGUnited Biotech, Inc.1993-08-103270
K905473UBI MAGIWEL CORTISOL QUANTITATIVEUnited Biotech, Inc.1991-01-31560
K910033UBI MAGIWEL(TM) ANA QUANTITATIVEUnited Biotech, Inc.1991-01-25210
K902897UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVEUnited Biotech, Inc.1990-07-16130
K883399UBI MAGIWEL CMV IGG QUANTITATIVEUnited Biotech, Inc.1989-03-272280
K883355UBI MAGIWEL RF-IGM QUANTITATIVEUnited Biotech, Inc.1988-09-07290
K864174UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVEUnited Biotech, Inc.1987-03-131400
K863442UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVEUnited Biotech, Inc.1987-02-041520
K864079UBI MAGIWEL(TM) TSH QUANTITATIVEUnited Biotech, Inc.1986-12-16570
K864075UBI MAGIWEL(TM) PROLACTIN QUANTATIVEUnited Biotech, Inc.1986-12-16570
K864142UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVEUnited Biotech, Inc.1986-12-03420
K864080UBI MAGIWEL(TM) FSH QUANTITATIVEUnited Biotech, Inc.1986-11-13240
K851076UBI HCG-MAGIWELL EIA EARLY PREGNANCY TESTUnited Biotech, Inc.1985-05-10530

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda