DIMENSION PSA FLEX REAGENT CARTRIDGE— 510(k) K003963
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K003963 for DIMENSION PSA FLEX REAGENT CARTRIDGE, Substantially Equivalent on 2001-02-28. Applicant: Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code LTJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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