FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3M ANTI-CARDIOLIPIN FAST(TM) TEST
K Number: K913054
·
Decision Nov 27, 1991
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
93
Applicant Total
4
Review Days
141
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
- 3M ANTI-CARDIOLIPIN FAST(TM) TEST
- K Number
- K913054
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- 3M Diagnostic Systems, Inc.
- Date Received
- July 9, 1991
- Decision Date
- November 27, 1991
- Product Code
- MID
- 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 |
|---|---|---|---|
| MID | System, Test, Anticardiolipin Immunological | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MID), ordered by most recent decision date.
Aptiva APS IgG Reagent; Aptiva APS IgM Reagent
FDA 510(k)
FDA Class 2
·Immunology
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
BIOPLEX 2200 APLS IGM
FDA 510(k)
FDA Class 2
·Immunology
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
FDA 510(k)
FDA Class 2
·Immunology
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
FDA 510(k)
FDA Class 2
·Immunology
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
FDA 510(k)
FDA Class 2
·Immunology