FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UBI MAGIWEL CMV IGG QUANTITATIVE
K Number: K883399
·
Decision Mar 27, 1989
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
57
Applicant Total
22
Review Days
228
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Basic Information
- Device Name
- UBI MAGIWEL CMV IGG QUANTITATIVE
- K Number
- K883399
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3175
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- United Biotech, Inc.
- Date Received
- August 11, 1988
- Decision Date
- March 27, 1989
- Product Code
- LFZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | FDA class 2 | Microbiology |
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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 |
| 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 |
| 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 |