Clearance Summary
PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST received FDA 510(k) clearance under submission number K861974, sponsored by Perceptive Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1986-08-04.
- Submission: K861974
- Applicant / Sponsor: Perceptive Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5260
- Decision date: 1986-08-04
Classification & Regulation
This clearance is catalogued under FDA product code LNJ and 21 CFR 864.5260, within the Hematology review panel as a Class II device.