FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EYE SPOT CRP TEST
K Number: K932180
·
Decision Aug 23, 1993
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
69
Applicant Total
18
Review Days
110
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EYE SPOT CRP TEST
- K Number
- K932180
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- J.S. Medical Assoc.
- Date Received
- May 5, 1993
- Decision Date
- August 23, 1993
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DCN), ordered by most recent decision date.
CardioPhase® hsCRP
FDA 510(k)
FDA Class 2
·Immunology
RCRP Flex reagent cartridge
FDA 510(k)
FDA Class 2
·Immunology
Tina-quant C-Reactive Protein IV
FDA 510(k)
FDA Class 2
·Immunology
Optilite High Sensitivity C-Reactive Protein Kit
FDA 510(k)
FDA Class 2
·Immunology
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
FDA 510(k)
FDA Class 2
·Immunology
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by J.S. Medical Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K932752 | VISI-SPOT | Nov 5, 1993 | Substantially Equivalent |
| K932688 | EYE SPOT IM TEST | Sep 8, 1993 | Substantially Equivalent |
| K932551 | ACCUTEX IM LATEX TEST | Aug 9, 1993 | Substantially Equivalent |
| K926112 | ACCUTEX BETA-HCG TEST | Jul 28, 1993 | Substantially Equivalent |
| K924332 | ACCUTEX CRP LATEX TEST | Dec 7, 1992 | Substantially Equivalent |
| K924247 | ACCUTEX ASO LATEX TEST | Dec 7, 1992 | Substantially Equivalent |
| K924036 | ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST | Dec 1, 1992 | Substantially Equivalent |
| K924037 | ACCUTEX IM RBC TEST | Nov 2, 1992 | Substantially Equivalent |
| K924248 | ACCUTEX SLE LATEX TEST | Nov 2, 1992 | Substantially Equivalent |
| K912717 | J&S UIBC REAGENTS | Sep 25, 1991 | Substantially Equivalent |