FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISOTYPES HUMAN IGG SUBCLASS EIA KIT
K Number: K920370
·
Decision Mar 11, 1992
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
1
Review Days
43
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
- ISOTYPES HUMAN IGG SUBCLASS EIA KIT
- K Number
- K920370
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Isotypes, Inc.
- Date Received
- January 28, 1992
- Decision Date
- March 11, 1992
- Product Code
- CGM
- 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 |
|---|---|---|---|
| CGM | Method, Immunodiffusion, Immunoglobulins (G, A, M) | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGM), ordered by most recent decision date.
HUMAN IGG SUBCLASS RID KIT
FDA 510(k)
FDA Class 2
·Immunology
IL TEST IMMUNOGLOBULIN G (IGG)
FDA 510(k)
FDA Class 2
·Immunology
IL TEST IMMUNOGLOBULIN M (IGM)
FDA 510(k)
FDA Class 2
·Immunology