FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT CMV-M EIA KIT
K Number: K872881
·
Decision May 13, 1988
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
17
Applicant Total
883
Review Days
296
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
- ABBOTT CMV-M EIA KIT
- K Number
- K872881
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3175
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- July 22, 1987
- Decision Date
- May 13, 1988
- Product Code
- LKQ
- 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 |
|---|---|---|---|
| LKQ | Antibody Igm,If, Cytomegalovirus Virus | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKQ), ordered by most recent decision date.
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
FDA 510(k)
FDA Class 2
·Microbiology
ACCURUN 146 CMV IGM POSITIVE CONTROL
FDA 510(k)
FDA Class 2
·Microbiology
VIDAS CMV IGM ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
BARTELS CYTOMEGALOVIRUS IGM EIA
FDA 510(k)
FDA Class 2
·Microbiology
ELISA CMV IGM
FDA 510(k)
FDA Class 2
·Microbiology
OPUS(R) ANTI CMV-M
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Abbott Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K252424 | Anti-HCV Next | Apr 28, 2026 | Substantially Equivalent |
| K243500 | ARCHITECT iGentamicin | Jul 9, 2025 | Substantially Equivalent |
| K243168 | Alinity i Rubella IgG | Jun 20, 2025 | Substantially Equivalent |
| K243283 | Alinity h-series System | Feb 20, 2025 | Substantially Equivalent |
| K233932 | Alinity i Toxo IgM | Aug 30, 2024 | Substantially Equivalent |
| K232669 | TBI | Sep 29, 2023 | Substantially Equivalent |
| K222850 | HAVAb IgG II | Aug 10, 2023 | Substantially Equivalent |
| K220031 | Alinity h-series System | Aug 4, 2023 | Substantially Equivalent |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Jul 14, 2023 | Substantially Equivalent |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Jun 5, 2023 | Substantially Equivalent |