FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOXOSTAT
K Number: K944867
·
Decision May 14, 1996
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
105
Applicant Total
3
Review Days
595
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Basic Information
- Device Name
- TOXOSTAT
- K Number
- K944867
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bio-Whittaker, Inc., A Cambrex Co.
- Date Received
- September 27, 1994
- Decision Date
- May 14, 1996
- 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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