SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000— 510(k) K992321
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K992321 for SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000, Substantially Equivalent on 1999-09-17. Applicant: Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code GKP
- Device class
- Class 2
- Regulation
- 21 CFR 864.5400
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.