510(k) K771198
K771198 is an FDA 510(k) premarket notification submitted by Chrono-Log Corp. for the device "LUMI-AGGREGOMETER". The FDA issued a decision of Substantially Equivalent on August 2, 1977. The device falls under product code JBY (Aggregometer, Platelet, Photo-Optical Scanning), a Class II device regulated under 21 CFR 864.6675. Chrono-Log Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 1977
- Date Received
- July 1, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aggregometer, Platelet, Photo-Optical Scanning
- Device Class
- Class II
- Regulation Number
- 864.6675
- Review Panel
- HE
- Submission Type