510(k) K820177
K820177 is an FDA 510(k) premarket notification submitted by Quadroma, Inc. for the device "COAGULASE PLASMA". The FDA issued a decision of Substantially Equivalent on February 5, 1982. The device falls under product code JTL (Plasma, Coagulase, Human, Horse And Rabbit), a Class I device regulated under 21 CFR 866.2160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 1982
- Date Received
- January 22, 1982
- 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