DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS— 510(k) K962150
Substantially EquivalentDade Intl., Inc.
FDA 510(k) clearance K962150 for DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS, Substantially Equivalent on 1996-08-16. Applicant: Dade Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Intl., Inc.
- Product code
- Code LTT
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Sacramento, CA, US
Recent devices under product code LTT
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- K250084 — MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
- K202343 — MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
- K201423 — MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)
More clearances from Dade Intl., Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.