Clearance Summary
ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K received FDA 510(k) clearance under submission number K990957, sponsored by Astoria-Pacific, 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 1999-05-11.
- Submission: K990957
- Applicant / Sponsor: Astoria-Pacific, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7360
- Decision date: 1999-05-11
Classification & Regulation
This clearance is catalogued under FDA product code JBL and 21 CFR 864.7360, within the Hematology review panel as a Class II device.