510(k) K822988
K822988 is an FDA 510(k) premarket notification submitted by American Scientific Products for the device "COAGULASE PLASMA-CITRATED & EDTA". The FDA issued a decision of Substantially Equivalent on November 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. American Scientific Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1982
- Date Received
- October 12, 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