Clearance Summary
RECONDITIONED ASTRA (TM) 8 received FDA 510(k) clearance under submission number K883298, sponsored by Associated Electro-Medical Services, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1989-03-16.
- Submission: K883298
- Applicant / Sponsor: Associated Electro-Medical Services, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2170
- Decision date: 1989-03-16
Classification & Regulation
This clearance is catalogued under FDA product code JJF and 21 CFR 862.2170, within the Clinical Chemistry review panel as a Class I device.