510(k) K863099
K863099 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT". The FDA issued a decision of Substantially Equivalent on Sep 16, 1986. The device falls under product code JJK (Oncometer, Plasma, For Clinical Use), a Class I device regulated under 21 CFR 862.2720. Abbott Laboratories has 889 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 16, 1986
- Date Received
- Aug 13, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Oncometer, Plasma, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2720
- Review Panel
- CH
- Submission Type
- 510(k) Exempt