510(k) K802840
K802840 is an FDA 510(k) premarket notification submitted by American Dade for the device "ALPHA-ANTIPLASM ASSAY". The FDA issued a decision of Substantially Equivalent on February 17, 1981. The device falls under product code LGP (Assay, Alpha-2-Antiplasmin), a Class II device regulated under 21 CFR 864.5425. American Dade has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1981
- Date Received
- November 12, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Alpha-2-Antiplasmin
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type