FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-RAD PLATELIA TOXO IGG TMB
K Number: K013839
·
Decision Sep 30, 2002
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
105
Applicant Total
319
Review Days
315
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Basic Information
- Device Name
- BIO-RAD PLATELIA TOXO IGG TMB
- K Number
- K013839
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Rad
- Date Received
- November 19, 2001
- Decision Date
- September 30, 2002
- 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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| K070361 | MRSASELECT | Sep 13, 2007 | Substantially Equivalent |
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