FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAGO DIFFU-GEN C-REACTIVE PROTEIN
K Number: K841265
·
Decision May 22, 1984
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
69
Applicant Total
8
Review Days
57
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
- TAGO DIFFU-GEN C-REACTIVE PROTEIN
- K Number
- K841265
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Tago, Inc.
- Date Received
- March 26, 1984
- Decision Date
- May 22, 1984
- Product Code
- DCN
- 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 |
|---|---|---|---|
| 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 Tago, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841734 | TAGO FIFFU-GEN, OROSOMUCOID | Jun 1, 1984 | Substantially Equivalent |
| K834218 | DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - | May 11, 1984 | Substantially Equivalent |
| K840404 | DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO | Mar 9, 1984 | Substantially Equivalent |
| K833129 | TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 | Nov 21, 1983 | Substantially Equivalent |
| K830611 | RA SCREENING TEST | Mar 24, 1983 | Substantially Equivalent |
| K830531 | MONO SCREENING TEST | Mar 17, 1983 | Substantially Equivalent |
| K830156 | HCG SCREENING TEST | Feb 9, 1983 | Substantially Equivalent |