FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WESBLOT RNP-SM TEST
K Number: K881379
·
Decision May 16, 1988
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
27
Applicant Total
3
Review Days
45
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
- WESBLOT RNP-SM TEST
- K Number
- K881379
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- American Bionetics, Inc.
- Date Received
- April 1, 1988
- Decision Date
- May 16, 1988
- Product Code
- LKP
- 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 |
|---|---|---|---|
| LKP | Anti-Sm Antibody, Antigen And Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKP), ordered by most recent decision date.
EliA SmDP-S
FDA 510(k)
FDA Class 2
·Immunology
EliA SmDP Immunoassay
FDA 510(k)
FDA Class 2
·Immunology
EIA SMDP IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,
FDA 510(k)
FDA Class 2
·Immunology
THERATEST EL-ANA PROFILES
FDA 510(k)
FDA Class 2
·Immunology
VARELISA SM ANTIBODIES, MODEL 18296
FDA 510(k)
FDA Class 2
·Immunology