FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UBI MAGIWEL AMPHETAMINE METABOLITES
K Number: K973153
·
Decision Oct 28, 1997
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
22
Review Days
67
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Basic Information
- Device Name
- UBI MAGIWEL AMPHETAMINE METABOLITES
- K Number
- K973153
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- United Biotech, Inc.
- Date Received
- August 22, 1997
- Decision Date
- October 28, 1997
- Product Code
- DJG
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
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Other Clearances by United Biotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981573 | UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE | Sep 15, 1998 | Substantially Equivalent |
| K973154 | UBI MAGIWEL MARIJUANA METABOLITES | Jul 22, 1998 | Substantially Equivalent |
| K973692 | UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE | Feb 9, 1998 | Substantially Equivalent |
| K973156 | UBI MAGIWEL COCAINE METABOLITES | Oct 28, 1997 | Substantially Equivalent |
| K973155 | UBI MAGIWEL OPIATE METABOLITES | Oct 28, 1997 | Substantially Equivalent |
| K962211 | UBI MAGIWEL THYROXINE (T4) QUANTITATIVE | Jul 8, 1996 | Substantially Equivalent |
| K961236 | UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE | May 30, 1996 | Substantially Equivalent |
| K951993 | UBI MAGIWEL FERRITIN QUANTITATIVE | Jul 5, 1995 | Substantially Equivalent |
| K924689 | UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG | Aug 10, 1993 | Substantially Equivalent |
| K905473 | UBI MAGIWEL CORTISOL QUANTITATIVE | Jan 31, 1991 | Substantially Equivalent |