FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479
K Number: K002453
·
Decision Aug 31, 2000
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
105
Applicant Total
270
Review Days
21
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Basic Information
- Device Name
- ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479
- K Number
- K002453
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter, Inc.
- Date Received
- August 10, 2000
- Decision Date
- August 31, 2000
- Product Code
- LGD
- 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 |
|---|---|---|---|
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | FDA class 2 | Microbiology |
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| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) | Aug 20, 2025 | Substantially Equivalent |
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