United Biotech
Deer Park, NY, US
UNITED BIOTECH appears in FDA device records in Deer Park, NY. FDA records list 22 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 22 510(k) clearances for United Biotech between 1985 and 1998. The busiest year on record is 1986, with 4. The most recent is 1998, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1986 | 4 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 2 |
| 1993 | 1 |
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 3 |
| 1998 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K981573 | UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE | JFH | Substantially Equivalent | |
| K973154 | UBI MAGIWEL MARIJUANA METABOLITES | LDJ | Substantially Equivalent | |
| K973692 | UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE | DCK | Substantially Equivalent | |
| K973156 | UBI MAGIWEL COCAINE METABOLITES | DJG | Substantially Equivalent | |
| K973155 | UBI MAGIWEL OPIATE METABOLITES | DJG | Substantially Equivalent | |
| K973153 | UBI MAGIWEL AMPHETAMINE METABOLITES | DJG | Substantially Equivalent | |
| K962211 | UBI MAGIWEL THYROXINE (T4) QUANTITATIVE | KLI | Substantially Equivalent | |
| K961236 | UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE | CDP | Substantially Equivalent | |
| K951993 | UBI MAGIWEL FERRITIN QUANTITATIVE | DBF | Substantially Equivalent | |
| K924689 | UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG | LYR | Substantially Equivalent | |
| K905473 | UBI MAGIWEL CORTISOL QUANTITATIVE | CGR | Substantially Equivalent | |
| K910033 | UBI MAGIWEL(TM) ANA QUANTITATIVE | LJM | Substantially Equivalent | |
| K902897 | UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE | LRM | Substantially Equivalent | |
| K883399 | UBI MAGIWEL CMV IGG QUANTITATIVE | LFZ | Substantially Equivalent | |
| K883355 | UBI MAGIWEL RF-IGM QUANTITATIVE | DHR | Substantially Equivalent | |
| K864174 | UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE | JHI | Substantially Equivalent | |
| K863442 | UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE | CEP | Substantially Equivalent | |
| K864079 | UBI MAGIWEL(TM) TSH QUANTITATIVE | JLW | Substantially Equivalent | |
| K864075 | UBI MAGIWEL(TM) PROLACTIN QUANTATIVE | CFT | Substantially Equivalent | |
| K864142 | UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE | DGC | Substantially Equivalent | |
| K864080 | UBI MAGIWEL(TM) FSH QUANTITATIVE | CGJ | Substantially Equivalent | |
| K851076 | UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST | JHI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004506204 | 3004506204 | UNITED BIOTECH | 45 W Jefryn Blvd, Suite E, Deer Park, NY 11729 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- FLGCleaner, Ultrasonic, Medical Instrument
- LDJEnzyme Immunoassay, Cannabinoids
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DJGEnzyme Immunoassay, Opiates
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- DBFFerritin, Antigen, Antiserum, Control
- LYRHelicobacter Pylori
- DGCIge, Antigen, Antiserum, Control
- CGRRadioimmunoassay, Cortisol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDPRadioimmunoassay, Total Triiodothyronine
- DHRSystem, Test, Rheumatoid Factor
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain