SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES— 510(k) K960220
Substantially EquivalentSensititre , Ltd.
FDA 510(k) clearance K960220 for SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES, Substantially Equivalent on 1996-03-11. Applicant: Sensititre , Ltd.. Device class: 2.
Clearance details
- Applicant
- Sensititre , Ltd.
- Product code
- Code JWY
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westlake, OH, US
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More clearances from Sensititre , Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.