FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNOMEDICS SERUM ELISA TEST SYSTEM
K Number: K861362
·
Decision Jun 6, 1986
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
43
Applicant Total
4
Review Days
57
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
- IMMUNOMEDICS SERUM ELISA TEST SYSTEM
- K Number
- K861362
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5240
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Immunomedics, Inc.
- Date Received
- April 10, 1986
- Decision Date
- June 6, 1986
- Product Code
- CZW
- 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 |
|---|---|---|---|
| CZW | Complement C3, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CZW), ordered by most recent decision date.
SPAPLUS
FDA 510(k)
FDA Class 2
·Immunology
COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
FDA 510(k)
FDA Class 2
·Immunology
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH
FDA 510(k)
FDA Class 2
·Immunology
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
FDA 510(k)
FDA Class 2
·Immunology
VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III
FDA 510(k)
FDA Class 2
·Immunology
IBL C3D-CIC EIA TEST
FDA 510(k)
FDA Class 2
·Immunology