SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES— 510(k) K092445
Substantially EquivalentTrek Diagnostic Systems, Ltd.
FDA 510(k) clearance K092445 for SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES, Substantially Equivalent on 2009-12-16. 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.
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- K110331 — SENSITITRE AIM (TM)
- K093741 — SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES
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Data sourced from openFDA. This site is unofficial and independent of the FDA.