FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXSYM VANCOMYCIN
K Number: K940595
·
Decision Jun 21, 1994
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
30
Applicant Total
883
Review Days
131
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
- AXSYM VANCOMYCIN
- K Number
- K940595
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3950
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- February 10, 1994
- Decision Date
- June 21, 1994
- Product Code
- LEH
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| LEH | Radioimmunoassay, Vancomycin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LEH), ordered by most recent decision date.
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ONLINE TDM Vancomycin Gen.3
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ARCHITECT IVANCOMYCIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
FDA 510(k)
FDA Class 2
·Clinical Toxicology
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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 |