TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE— 510(k) K994115
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K994115 for TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE, Substantially Equivalent on 2000-01-28. Applicant: Dade Behring, Inc.. Device class: 1.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code JMO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1415
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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Recalls naming K994115
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 K994115.
Data sourced from openFDA. This site is unofficial and independent of the FDA.