SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES— 510(k) K011803
Substantially EquivalentTrek Diagnostic Systems, Inc.
FDA 510(k) clearance K011803 for SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES, Substantially Equivalent on 2001-08-15. Applicant: Trek Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Trek Diagnostic Systems, Inc.
- 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 Trek Diagnostic Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.