FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
K Number: K001875
·
Decision Aug 21, 2000
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
93
Applicant Total
68
Review Days
62
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Basic Information
- Device Name
- DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
- K Number
- K001875
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diamedix Corp.
- Date Received
- June 20, 2000
- Decision Date
- August 21, 2000
- Product Code
- LFX
- 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 |
|---|---|---|---|
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | FDA class 2 | Microbiology |
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Other Clearances by Diamedix Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K093101 | MAGO 4S | Jan 21, 2011 | Substantially Equivalent |
| K021394 | DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM | Jul 9, 2002 | Substantially Equivalent |
| K013956 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN | Jan 8, 2002 | Substantially Equivalent |
| K013628 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM | Dec 21, 2001 | Substantially Equivalent |
| K012450 | DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM | Oct 26, 2001 | Substantially Equivalent |
| K012449 | DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM | Oct 26, 2001 | Substantially Equivalent |
| K012795 | DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM | Sep 28, 2001 | Substantially Equivalent |
| K012797 | DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM | Sep 28, 2001 | Substantially Equivalent |
| K012053 | DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM | Aug 20, 2001 | Substantially Equivalent |
| K002262 | DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM | Nov 28, 2000 | Substantially Equivalent |