FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Elecsys Anti-HAV IgM
K Number: K260048
·
Decision Apr 7, 2026
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
25
Applicant Total
183
Review Days
90
Basic Information
- Device Name
- Elecsys Anti-HAV IgM
- K Number
- K260048
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3310
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- January 7, 2026
- Decision Date
- April 7, 2026
- Product Code
- LOL
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LOL | Hepatitis A Test (Antibody And Igm Antibody) | FDA class 2 | Microbiology |
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