Clearance Summary
TEMPERATURE REGULATED FIVE CELL HOLDERS received FDA 510(k) clearance under submission number K760769, 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 1976-11-30.
- Submission: K760769
- Applicant / Sponsor: The Perkin-Elmer Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 1976-11-30
Classification & Regulation
This clearance is catalogued under FDA product code JRI and 21 CFR 862.2050, within the Clinical Chemistry review panel as a Class I device.