510(k) K833708
K833708 is an FDA 510(k) premarket notification submitted by Worthington Diagnostic Systems for the device "COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE". The FDA issued a decision of Substantially Equivalent on January 4, 1984. The device falls under product code LKZ (Red-Cell Count By Photometry), a Class II device regulated under 21 CFR 864.7100. Worthington Diagnostic Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 1984
- Date Received
- October 20, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Red-Cell Count By Photometry
- Device Class
- Class II
- Regulation Number
- 864.7100
- Review Panel
- HE
- Submission Type