MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST— 510(k) K991810
Substantially EquivalentTrek Diagnostic Systems, Inc.
FDA 510(k) clearance K991810 for MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST, Substantially Equivalent on 2001-10-09. Applicant: Trek Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Trek Diagnostic Systems, Inc.
- Product code
- Code NGZ
- 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.