TGL FLEX REAGENT CARTRIDGE— 510(k) K010871
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K010871 for TGL FLEX REAGENT CARTRIDGE, Substantially Equivalent on 2001-07-09. Applicant: Dade Behring, Inc.. Device class: 1.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code CDT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1705
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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Recalls naming K010871
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 K010871.
Data sourced from openFDA. This site is unofficial and independent of the FDA.