Clearance Summary
SPECTROPHOTOMETERS received FDA 510(k) clearance under submission number K780342, 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 1978-04-10.
- Submission: K780342
- Applicant / Sponsor: The Perkin-Elmer Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2850
- Decision date: 1978-04-10
Classification & Regulation
This clearance is catalogued under FDA product code JXR and 21 CFR 862.2850, within the Clinical Chemistry review panel as a Class I device.