SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN— 510(k) K983301
Substantially EquivalentAccumed Intl., Inc.
FDA 510(k) clearance K983301 for SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN, Substantially Equivalent on 1998-11-25. Applicant: Accumed Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Accumed Intl., 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 Accumed Intl., Inc.
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- K983310 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN
- K983309 — SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
- K982786 — TRACCELL 2000 SLIDE MAPPING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.