FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAICHEM(TM) SPIA(TM) CRP REAGENT
K Number: K902593
·
Decision Jun 28, 1990
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
69
Applicant Total
63
Review Days
16
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Basic Information
- Device Name
- RAICHEM(TM) SPIA(TM) CRP REAGENT
- K Number
- K902593
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Reagents Applications, Inc.
- Date Received
- June 12, 1990
- Decision Date
- June 28, 1990
- Product Code
- DCN
- 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 |
|---|---|---|---|
| DCN | System, Test, C-Reactive Protein | FDA class 2 | Immunology |
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Other Clearances by Reagents Applications, Inc.
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|---|---|---|---|
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| 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 |