CHEMPRO 1000(TM)— 510(k) K870860
Substantially EquivalentArden Medical Systems, Inc.
FDA 510(k) clearance K870860 for CHEMPRO 1000(TM), Substantially Equivalent on 1987-04-14. Applicant: Arden Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Arden Medical Systems, Inc.
- Product code
- Code GKF
- Device class
- Class 2
- Regulation
- 21 CFR 864.5600
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arden Hills, MN, US
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