510(k) K870860
K870860 is an FDA 510(k) premarket notification submitted by Arden Medical Systems, Inc. for the device "CHEMPRO 1000(TM)". The FDA issued a decision of Substantially Equivalent on April 14, 1987. The device falls under product code GKF (Instrument, Hematocrit, Automated), a Class II device regulated under 21 CFR 864.5600. Arden Medical Systems, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 1987
- Date Received
- March 3, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Hematocrit, Automated
- Device Class
- Class II
- Regulation Number
- 864.5600
- Review Panel
- HE
- Submission Type