FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SENSI-TECT
K Number: K812581
·
Decision Sep 23, 1981
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
73
Applicant Total
3
Review Days
13
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Basic Information
- Device Name
- SENSI-TECT
- K Number
- K812581
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Uti-Tect, Inc.
- Date Received
- September 10, 1981
- Decision Date
- September 23, 1981
- Product Code
- JTZ
- 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 |
|---|---|---|---|
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | FDA class 2 | Microbiology |
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