510(k) K781807
K781807 is an FDA 510(k) premarket notification submitted by Chrono-Log Corp. for the device "REAGENT, FIREFLY #395". The FDA issued a decision of Substantially Equivalent on November 22, 1978. The device falls under product code JOZ (System, Automated Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Chrono-Log Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 1978
- Date Received
- October 25, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Automated Platelet Aggregation
- Device Class
- Class II
- Regulation Number
- 864.5700
- Review Panel
- HE
- Submission Type