510(k) K823761
K823761 is an FDA 510(k) premarket notification submitted by Cordis Corp. for the device "ERYTHROCYTE & STAND SEDIMENT. RATE TUBE". The FDA issued a decision of Substantially Equivalent on January 21, 1983. The device falls under product code JPH (Test, Erythrocyte Sedimentation Rate), a Class I device regulated under 21 CFR 864.6700. Cordis Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1983
- Date Received
- December 14, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Erythrocyte Sedimentation Rate
- Device Class
- Class I
- Regulation Number
- 864.6700
- Review Panel
- HE
- Submission Type