FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TIA-IGG REAGENT & CALIBRATOR SETS
K Number: K831101
·
Decision Apr 27, 1983
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
75
Applicant Total
19
Review Days
22
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
- TIA-IGG REAGENT & CALIBRATOR SETS
- K Number
- K831101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Worthington Diagnostic Systems
- Date Received
- April 5, 1983
- Decision Date
- April 27, 1983
- Product Code
- DEW
- 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 |
|---|---|---|---|
| DEW | Igg, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DEW), ordered by most recent decision date.
TINA-QUANT IGG GEN.2
FDA 510(k)
FDA Class 2
·Immunology
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
FDA 510(k)
FDA Class 2
·Immunology
SPIFE IFE CALIBRATOR AND CONTROL KIT
FDA 510(k)
FDA Class 2
·Immunology
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
FDA 510(k)
FDA Class 2
·Immunology
K-ASSAY IGG
FDA 510(k)
FDA Class 2
·Immunology
IGG
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Worthington Diagnostic Systems
| K Number | Device Name | ||
|---|---|---|---|
| K833708 | COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE | Jan 4, 1984 | Substantially Equivalent |
| K832748 | COMPUR* EASYTOUCH TOTAL BILIRUBIN | Oct 14, 1983 | Substantially Equivalent |
| K832427 | EASYTOUCH TROMBOPLASTIN REAGENT | Oct 14, 1983 | Substantially Equivalent |
| K832785 | COMPUR* EASY TOUCH URIC ACID REAGENT | Oct 14, 1983 | Substantially Equivalent |
| K832749 | EASYTOUCH BUN REAGENT SET | Oct 14, 1983 | Substantially Equivalent |
| K832750 | EASYTOUCH HEMOGLOBIN REAGENT | Sep 26, 1983 | Substantially Equivalent |
| K832426 | EASYTOUCH TRIGLYCERIDES REAGENT SET | Sep 12, 1983 | Substantially Equivalent |
| K831477 | DEMAND ANALYZER SYSTEM | Jun 17, 1983 | Substantially Equivalent |
| K831318 | COMPUR* M1100 HEMATRCRIT SYSTEM | Jun 8, 1983 | Substantially Equivalent |
| K831227 | COMPUR EASY TOUCH CHEMISTRY ANALYZER- | Jun 2, 1983 | Substantially Equivalent |