SENSI-TECT— 510(k) K812581
Substantially EquivalentUti-Tect, Inc.
FDA 510(k) clearance K812581 for SENSI-TECT, Substantially Equivalent on 1981-09-23. Applicant: Uti-Tect, Inc.. Device class: 2.
Clearance details
- Applicant
- Uti-Tect, Inc.
- Product code
- Code JTZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.1700
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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