FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT
K Number: K900875
·
Decision Mar 6, 1990
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
47
Applicant Total
63
Review Days
8
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Basic Information
- Device Name
- RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT
- K Number
- K900875
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5880
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Reagents Applications, Inc.
- Date Received
- February 26, 1990
- Decision Date
- March 6, 1990
- Product Code
- DDG
- Advisory Committee
- Immunology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| DDG | Transferrin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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Other Clearances by Reagents Applications, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982056 | RAICHEM CO2 REAGENT | Jun 24, 1998 | Substantially Equivalent |
| K972853 | CHOLESTEROL RAPID LIQUID REAGENT | Sep 24, 1997 | Substantially Equivalent |
| K922904 | RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II | Jul 30, 1992 | Substantially Equivalent |
| K915191 | RAI-TROL ELEVATED LIPIDS CONTROL | Dec 18, 1991 | Substantially Equivalent |
| K913398 | RAICHEM(TM) CREATINE KINASE-MB REAGENT | Sep 25, 1991 | Substantially Equivalent |
| K911900 | RAICHEM SPIA C3 REAGENT | May 9, 1991 | Substantially Equivalent |
| K911899 | RAICHEM SPIA C4 REAGENT | May 9, 1991 | Substantially Equivalent |
| K911898 | RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT | May 8, 1991 | Substantially Equivalent |
| K905084 | RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV | Dec 20, 1990 | Substantially Equivalent |
| K905085 | RAICHEM GGT REAGENT | Dec 20, 1990 | Substantially Equivalent |