FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTIHUMAN IGG GLOBULIN FITC LABELED
K Number: K821018
·
Decision Apr 29, 1982
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
75
Applicant Total
14
Review Days
17
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
- ANTIHUMAN IGG GLOBULIN FITC LABELED
- K Number
- K821018
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Microbiological Research Corp.
- Date Received
- April 12, 1982
- Decision Date
- April 29, 1982
- 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 Microbiological Research Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K883011 | MRI NEO-TRYP TRYPSIN RIA | Apr 26, 1989 | Substantially Equivalent |
| K861121 | THE GOLDEN QUAD TEST (EBV) | Feb 2, 1987 | Substantially Equivalent |
| K861123 | THE GOLDEN QUAD TEST (CMV) | Feb 2, 1987 | Substantially Equivalent |
| K861122 | THE GOLDEN QUAD TEST (TOXO) | Feb 2, 1987 | Substantially Equivalent |
| K861120 | THE GOLDEN QUAD TEST (HSV) | Feb 2, 1987 | Substantially Equivalent |
| K860450 | THE CMV-IGM TEST | May 13, 1986 | Substantially Equivalent |
| K843138 | CMV TEST | Jan 29, 1985 | Substantially Equivalent |
| K821019 | PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU | Apr 26, 1982 | Substantially Equivalent |
| K803134 | TOXOPLASMA GONDII SEROLOGICAL REAGENTS | Jan 29, 1981 | Substantially Equivalent |
| K803133 | RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL | Jan 29, 1981 | Substantially Equivalent |