FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GC OIA
K Number: K023947
·
Decision Apr 17, 2003
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
5
Review Days
141
Basic Information
- Device Name
- GC OIA
- K Number
- K023947
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- THERMO BIOSTAR, INC.
- Date Received
- November 27, 2002
- Decision Date
- April 17, 2003
- Product Code
- LIR
- 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 |
|---|---|---|---|
| LIR | Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae | FDA class 2 | Microbiology |
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