FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)
K Number: K962836
·
Decision Sep 12, 1996
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
143
Applicant Total
52
Review Days
52
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Basic Information
- Device Name
- HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)
- K Number
- K962836
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hemagen Diagnostics, Inc.
- Date Received
- July 22, 1996
- Decision Date
- September 12, 1996
- Product Code
- DHR
- 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 |
|---|---|---|---|
| DHR | System, Test, Rheumatoid Factor | FDA class 2 | Immunology |
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Other Clearances by Hemagen Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K041052 | RAICHEM GLUCOSE UV (LIQUID) | Jun 30, 2004 | Substantially Equivalent |
| K041051 | RAICHEM BUN RATE REAGENT (LIQUID) | Jun 30, 2004 | Substantially Equivalent |
| K041009 | RAICHEM CALCIUM (OCPC) LIQUID REAGENT | Jun 25, 2004 | Substantially Equivalent |
| K031101 | RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 | Jun 16, 2003 | Substantially Equivalent |
| K023784 | RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER | Dec 24, 2002 | Substantially Equivalent |
| K022772 | RAICHEM LDL-CHOLESTEROL DIRECT REAGENT | Sep 17, 2002 | Substantially Equivalent |
| K022767 | RAICHEM LIPID CALIBRATOR | Sep 3, 2002 | Substantially Equivalent |
| K021194 | RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM | Jul 29, 2002 | Substantially Equivalent |
| K022049 | MODIFICATION TO RAICHEM CALCIUM REAGENT | Jul 19, 2002 | Substantially Equivalent |
| K012649 | RAICHEM BUN RATE REAGENT | Oct 15, 2001 | Substantially Equivalent |