Clearance Summary
CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) received FDA 510(k) clearance under submission number K990579, sponsored by Precision Biologic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1999-07-23.
- Submission: K990579
- Applicant / Sponsor: Precision Biologic
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8950
- Decision date: 1999-07-23
Classification & Regulation
This clearance is catalogued under FDA product code GIR and 21 CFR 864.8950, within the Hematology review panel as a Class I device.