FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAMMADAB[125]EGE RADIOIMMUNOASSAY IT
K Number: K821092
·
Decision Jun 22, 1982
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
113
Applicant Total
27
Review Days
64
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
- GAMMADAB[125]EGE RADIOIMMUNOASSAY IT
- K Number
- K821092
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Clinical Assays, Inc.
- Date Received
- April 19, 1982
- Decision Date
- June 22, 1982
- 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 Clinical Assays, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K832711 | VITAMIN B12 FOLATE CA-1515-125 | Oct 4, 1983 | Substantially Equivalent |
| K832712 | FOLATE RADIOASSAY KIT CA-1562-125 | Oct 4, 1983 | Substantially Equivalent |
| K832710 | VITAMIN B12 RADIOASSAY KIT CA-1534 | Oct 4, 1983 | Substantially Equivalent |
| K823476 | GAMMADAB LH RADIO-KIT #CA-1508 | Dec 28, 1982 | Substantially Equivalent |
| K823313 | IN VITRO GAMMACOAT B-HCG RADIO. TEST | Dec 22, 1982 | Substantially Equivalent |
| K821611 | GAMMADAB [125] FSH RADIOIMMUNAY KIT | Jun 24, 1982 | Substantially Equivalent |
| K812227 | GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY | Sep 24, 1981 | Substantially Equivalent |
| K810722 | GASTRIN RADIOIMMUNOASSAY TEST | May 27, 1981 | Substantially Equivalent |
| K810967 | IN-VITRO TBG RADIOIMMUNOASSAY TEST | Apr 23, 1981 | Substantially Equivalent |
| K801667 | GAMMA COAT(125 I) RUBELLA ANTIBODY | Oct 23, 1980 | Substantially Equivalent |