FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MDI DS-DNA TEST
K Number: K000477
·
Decision Mar 1, 2000
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
28
Applicant Total
11
Review Days
16
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Basic Information
- Device Name
- MDI DS-DNA TEST
- K Number
- K000477
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micro Detect, Inc.
- Date Received
- February 14, 2000
- Decision Date
- March 1, 2000
- 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.
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FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
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VARELISA SSDNA ANTIBODIES, MODEL 14896
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ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
FDA 510(k)
FDA Class 2
·Immunology
DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Micro Detect, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003794 | ELISA TEST, SEROLOGY | Mar 30, 2001 | Substantially Equivalent |
| K002358 | MDI GLIADIN A TEST | Oct 19, 2000 | Substantially Equivalent |
| K002359 | MDI GLIADIN G TEST | Oct 19, 2000 | Substantially Equivalent |
| K000934 | MDI SCL-70 TEST | Apr 7, 2000 | Substantially Equivalent |
| K994029 | MDI SM TEST | Jan 11, 2000 | Substantially Equivalent |
| K993843 | MDI RF TEST | Jan 11, 2000 | Substantially Equivalent |
| K993971 | MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM | Jan 11, 2000 | Substantially Equivalent |
| K993636 | MDI SS-A TEST | Jan 10, 2000 | Substantially Equivalent |
| K993635 | MDI SM/RNP TEST | Jan 10, 2000 | Substantially Equivalent |
| K973508 | PYLORI DETECT IGG | Mar 10, 1998 | Substantially Equivalent |