FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EZ COMPLEMENT C2
K Number: K892125
·
Decision Apr 14, 1989
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
43
Applicant Total
68
Review Days
18
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Basic Information
- Device Name
- EZ COMPLEMENT C2
- K Number
- K892125
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5240
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Diamedix Corp.
- Date Received
- March 27, 1989
- Decision Date
- April 14, 1989
- Product Code
- CZW
- 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 |
|---|---|---|---|
| CZW | Complement C3, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CZW), ordered by most recent decision date.
SPAPLUS
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N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
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VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III
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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 |