510(k) K890503
K890503 is an FDA 510(k) premarket notification submitted by Gespac, Inc. for the device "SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE". The FDA issued a decision of Substantially Equivalent on February 10, 1989. The device falls under product code GKB (Device, Automated Sedimentation Rate), a Class I device regulated under 21 CFR 864.5800. Gespac, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1989
- Date Received
- February 1, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Automated Sedimentation Rate
- Device Class
- Class I
- Regulation Number
- 864.5800
- Review Panel
- HE
- Submission Type