DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE— 510(k) K970330
Substantially EquivalentDade Intl., Inc.
FDA 510(k) clearance K970330 for DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE, Substantially Equivalent on 1997-04-14. Applicant: Dade Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Intl., Inc.
- Product code
- Code CEM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1600
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code CEM
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view allRecalls naming K970330
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970330.
Data sourced from openFDA. This site is unofficial and independent of the FDA.