Clearance Summary
SPECTROPHOTOMETER, MODEL 597 IR received FDA 510(k) clearance under submission number K770288, sponsored by The Perkin-Elmer Corp.. 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 1977-03-10.
- Submission: K770288
- Applicant / Sponsor: The Perkin-Elmer Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2300
- Decision date: 1977-03-10
Classification & Regulation
This clearance is catalogued under FDA product code JJQ and 21 CFR 862.2300, within the Clinical Chemistry review panel as a Class I device.