FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE
K Number: K902897
·
Decision Jul 16, 1990
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
28
Applicant Total
22
Review Days
13
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE
- K Number
- K902897
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- United Biotech, Inc.
- Date Received
- July 3, 1990
- Decision Date
- July 16, 1990
- Product Code
- LRM
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRM), ordered by most recent decision date.
IMMULISA DSDNA ANTIBODY ELISA
FDA 510(k)
FDA Class 2
·Immunology
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
FDA 510(k)
FDA Class 2
·Immunology
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Immunology
VARELISA SSDNA ANTIBODIES, MODEL 14896
FDA 510(k)
FDA Class 2
·Immunology
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
FDA 510(k)
FDA Class 2
·Immunology
MDI DS-DNA TEST
FDA 510(k)
FDA Class 2
·Immunology
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 |