FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME
K Number: K811721
·
Decision Jul 16, 1981
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
15
Review Days
28
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
- H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME
- K Number
- K811721
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Immulok, Inc.
- Date Received
- June 18, 1981
- Decision Date
- July 16, 1981
- Product Code
- DFH
- Advisory Committee
- Immunology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| DFH | Kappa, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DFH), ordered by most recent decision date.
Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
FDA 510(k)
FDA Class 2
·Immunology
Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit
FDA 510(k)
FDA Class 2
·Immunology
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
FDA 510(k)
FDA Class 2
·Immunology
Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
FDA 510(k)
FDA Class 2
·Immunology
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
FDA 510(k)
FDA Class 2
·Immunology
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Immulok, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830971 | HERPES SIMPLEX VIRUS TYPING REAGENTS | Jun 30, 1983 | Substantially Equivalent |
| K830342 | CULUTURE SET CHLAMYDIA ISOLATION AND | May 4, 1983 | Substantially Equivalent |
| K830250 | CVT VIRAL TRANSPORTS | Feb 28, 1983 | Substantially Equivalent |
| K823304 | RIASET PROLACTIN RIA KIT | Dec 22, 1982 | Substantially Equivalent |
| K822785 | FLUOROSET IMMUNOFLUORESCENT ANTIBODY | Nov 29, 1982 | Substantially Equivalent |
| K823055 | FLOUROSET IMMUNOFLUORESCENT ANTIBODY | Nov 5, 1982 | Substantially Equivalent |
| K822606 | CYTOMEGALOVIRUS ANTOBODY IGG | Nov 1, 1982 | Substantially Equivalent |
| K822605 | TOXOPLASMA GONDII ANTIBODY IGG | Oct 27, 1982 | Substantially Equivalent |
| K822607 | ANTINUCLEAR ANTOBODY CELL SUBSTRATE | Sep 17, 1982 | Substantially Equivalent |
| K821567 | IMMULOK CULTURESET | Jun 25, 1982 | Substantially Equivalent |