510(k) K792235
K792235 is an FDA 510(k) premarket notification submitted by Remel Co. for the device "COAGULASE PLASMA". The FDA issued a decision of Substantially Equivalent on December 7, 1979. The device falls under product code JTL (Plasma, Coagulase, Human, Horse And Rabbit), a Class I device regulated under 21 CFR 866.2160. Remel Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1979
- Date Received
- November 6, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plasma, Coagulase, Human, Horse And Rabbit
- Device Class
- Class I
- Regulation Number
- 866.2160
- Review Panel
- MI
- Submission Type