MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML)— 510(k) K020506
Substantially EquivalentDade Microscan, Inc.
FDA 510(k) clearance K020506 for MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML), Substantially Equivalent on 2002-04-17. Applicant: Dade Microscan, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Microscan, Inc.
- Product code
- Code LON
- Device class
- Class 2
- Regulation
- 21 CFR 866.1645
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Sacramento, CA, US
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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
Adverse events under product code LON
product code LON- Malfunction
- 2,383
- Total
- 2,383
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.