FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE
K Number: K961236
·
Decision May 30, 1996
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
143
Applicant Total
22
Review Days
62
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Basic Information
- Device Name
- UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE
- K Number
- K961236
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1710
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- United Biotech, Inc.
- Date Received
- March 29, 1996
- Decision Date
- May 30, 1996
- Product Code
- CDP
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDP), ordered by most recent decision date.
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
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CHIRON DIAGNOSTICS ACS: 180 FT3
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TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
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·Clinical Chemistry
AIA-PACK FT3 ASSAY
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OPTICOAT T3 EIA KIT
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FDA Class 2
·Clinical Chemistry
ABBOTT ARCHITECT FREE T3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |
| K973153 | UBI MAGIWEL AMPHETAMINE METABOLITES | Oct 28, 1997 | 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 |
| 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 |