510(k) K862775
K862775 is an FDA 510(k) premarket notification submitted by American Bioproducts Co. for the device "ASSERACHROM B-TG KIT". The FDA issued a decision of Substantially Equivalent on Oct 22, 1986. The device falls under product code JBX (Aggregrometer, Platelet), a Class II device regulated under 21 CFR 864.6675. American Bioproducts Co. has 78 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 22, 1986
- Date Received
- Jul 22, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Aggregrometer, Platelet
- Device Class
- Class II
- Regulation Number
- 864.6675
- Review Panel
- HE
- Submission Type
- 510(k)