FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SENSITITRE ARIS MODULE
K Number: K911419
·
Decision Jul 1, 1992
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
44
Applicant Total
3
Review Days
457
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Basic Information
- Device Name
- SENSITITRE ARIS MODULE
- K Number
- K911419
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Sensititre , Ltd.
- Date Received
- April 1, 1991
- Decision Date
- July 1, 1992
- Product Code
- LRG
- 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 |
|---|---|---|---|
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | FDA class 2 | Microbiology |
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