Clearance Summary
ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE received FDA 510(k) clearance under submission number K981897, sponsored by Roche Diagnostic Systems, 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 1998-08-26.
- Submission: K981897
- Applicant / Sponsor: Roche Diagnostic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1050
- Decision date: 1998-08-26
Classification & Regulation
This clearance is catalogued under FDA product code CJE and 21 CFR 862.1050, within the Clinical Chemistry review panel as a Class II device.