FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL
K Number: K896272
·
Decision Nov 8, 1989
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
69
Applicant Total
16
Review Days
9
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
- QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL
- K Number
- K896272
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Biokit USA, Inc.
- Date Received
- October 30, 1989
- Decision Date
- November 8, 1989
- 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 Biokit USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913467 | TOXOGEN | Jan 11, 1993 | Substantially Equivalent |
| K910541 | BIOKIT RPR | Oct 18, 1991 | Substantially Equivalent |
| K904310 | RHEUMAGEN RF T-CONTROL | May 31, 1991 | Substantially Equivalent |
| K910539 | RHEUMAJET RF | Apr 5, 1991 | Substantially Equivalent |
| K910686 | RHEUMAJET CRP | Mar 19, 1991 | Substantially Equivalent |
| K904311 | RHEUMAGEN ASO T-CONTROL | Jan 25, 1991 | Substantially Equivalent |
| K904312 | RHEUMAGEN CRP T-CONTROL | Oct 1, 1990 | Substantially Equivalent |
| K896433 | MODIFIED RUBAGEN | Nov 29, 1989 | Substantially Equivalent |
| K896271 | QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) | Nov 8, 1989 | Substantially Equivalent |
| K894486 | QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) | Oct 24, 1989 | Substantially Equivalent |