FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAN DEM* - IGE KIT
K Number: K802913
·
Decision May 29, 1981
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
113
Applicant Total
63
Review Days
192
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
- TAN DEM* - IGE KIT
- K Number
- K802913
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Hybritech, Inc.
- Date Received
- November 18, 1980
- Decision Date
- May 29, 1981
- Product Code
- DGC
- 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 |
|---|---|---|---|
| DGC | Ige, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DGC), ordered by most recent decision date.
Kenota 1 Total IgE; Kenota 1 (instrument)
FDA 510(k)
FDA Class 2
·Immunology
Quantia IgE
FDA 510(k)
FDA Class 2
·Immunology
Total Immunoglobulin E (IgE)
FDA 510(k)
FDA Class 2
·Immunology
ADVIA Centaur Total IgE (tIgE)
FDA 510(k)
FDA Class 2
·Immunology
ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
FDA 510(k)
FDA Class 2
·Immunology
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Hybritech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972666 | TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY | Sep 11, 1997 | Substantially Equivalent |
| K961573 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | Aug 19, 1996 | Substantially Equivalent |
| K930810 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | Jan 11, 1994 | Substantially Equivalent |
| K922754 | TANDEM-E IGE II CALIBRATION VERIFICATION SET | Feb 17, 1993 | Substantially Equivalent |
| K921745 | HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO | Jul 30, 1992 | Substantially Equivalent |
| K921252 | TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL | Jul 17, 1992 | Substantially Equivalent |
| K920556 | TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET | Jul 17, 1992 | Substantially Equivalent |
| K921763 | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY | Jun 9, 1992 | Substantially Equivalent |
| K912439 | TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET | Aug 28, 1991 | Substantially Equivalent |
| K911417 | ICON STREP B IMMUNOENZYMETRIC ASSAY | Jul 24, 1991 | Substantially Equivalent |