DRIED GRAM-POSITIVE MIC/COMBO PANELS— 510(k) K993102
Substantially EquivalentDade Microscan, Inc.
FDA 510(k) clearance K993102 for DRIED GRAM-POSITIVE MIC/COMBO PANELS, Substantially Equivalent on 1999-12-02. Applicant: Dade Microscan, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Microscan, 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
view all- K243804 — MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
- K250036 — MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
- 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 Microscan, Inc.
view all- K043589 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM
- K023202 — MICROSCAN SYNERGIES PLUS
- K021184 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN
- K021181 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN
- K021018 — MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL
Data sourced from openFDA. This site is unofficial and independent of the FDA.