FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MDI SM TEST
K Number: K994029
·
Decision Jan 11, 2000
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
179
Applicant Total
11
Review Days
46
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Basic Information
- Device Name
- MDI SM TEST
- K Number
- K994029
- 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
- November 26, 1999
- Decision Date
- January 11, 2000
- Product Code
- LLL
- 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 |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | FDA class 2 | Immunology |
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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 |
| K000477 | MDI DS-DNA TEST | Mar 1, 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 |