510(k) K820422
K820422 is an FDA 510(k) premarket notification submitted by Chrono-Log Corp. for the device "PLATELET AGGREGOMETERS". The FDA issued a decision of Substantially Equivalent on Mar 16, 1982. The device falls under product code GHR (Reagent, Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Chrono-Log Corp. has 15 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 16, 1982
- Date Received
- Feb 16, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Reagent, Platelet Aggregation
- Device Class
- Class II
- Regulation Number
- 864.5700
- Review Panel
- HE
- Submission Type
- 510(k)