FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMMUNOWELL VCA IGM TEST
K Number: K973939
·
Decision Aug 10, 1998
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
22
Applicant Total
10
Review Days
299
Basic Information
- Device Name
- IMMUNOWELL VCA IGM TEST
- K Number
- K973939
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GenBio
- Date Received
- October 15, 1997
- Decision Date
- August 10, 1998
- Product Code
- LJN
- 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 |
|---|---|---|---|
| LJN | Antibody Igm, If, Epstein-Barr Virus | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJN), ordered by most recent decision date.
BIOPLEX 2200 EBV IGM KIT
FDA 510(k)
FDA Class 1
·Microbiology
PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
FDA 510(k)
FDA Class 1
·Microbiology
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
MODIFICATION TO SERAQUEST VCA IGM
FDA 510(k)
FDA Class 1
·Microbiology
SERAQUEST EB VAC IGM
FDA 510(k)
FDA Class 1
·Microbiology
COPALIS EBV-M ANTIBODY ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by GenBio
| K Number | Device Name | ||
|---|---|---|---|
| K010301 | IMMUNOWELL EA (D) IGG TEST | Jun 11, 2001 | Substantially Equivalent |
| K974226 | IMMUNODOT MONO-G TEST | Sep 22, 1998 | Substantially Equivalent |
| K974244 | IMMUNODOT MONO-M TEST | Sep 22, 1998 | Substantially Equivalent |
| K973940 | IMMUNOWELL EBV VCA IGG TEST | Aug 10, 1998 | Substantially Equivalent |
| K973941 | IMMUNOWELL EBNA IGG TEST | Aug 10, 1998 | Substantially Equivalent |
| K963054 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) | May 5, 1997 | Substantially Equivalent |
| K963055 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 | May 2, 1997 | Substantially Equivalent |
| K953683 | MMUNO DOT BORRELIA DOT BLOT M TEST | May 3, 1996 | Substantially Equivalent |
| K953682 | IMMUNO DOT BORRELIA DOT BLOT G TEST | May 3, 1996 | Substantially Equivalent |