Clearance Summary
REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 received FDA 510(k) clearance under submission number K931465, sponsored by Helena Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1993-07-06.
- Submission: K931465
- Applicant / Sponsor: Helena Laboratories
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7440
- Decision date: 1993-07-06
Classification & Regulation
This clearance is catalogued under FDA product code JBD and 21 CFR 864.7440, within the Hematology review panel as a Class II device.