SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...— 510(k) K111429
Substantially EquivalentTrek Diagnostic Systems, Ltd.
FDA 510(k) clearance K111429 for SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE..., Substantially Equivalent on 2011-08-18. Applicant: Trek Diagnostic Systems, Ltd.. Device class: 2.
Clearance details
- Applicant
- Trek Diagnostic Systems, 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
- Cleveland, OH, US
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More clearances from Trek Diagnostic Systems, Ltd.
view allRecalls naming K111429
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111429.
Data sourced from openFDA. This site is unofficial and independent of the FDA.