Clearance Summary
DETECTOR, IR, MODEL GC-33 received FDA 510(k) clearance under submission number K770639, sponsored by Peokin-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 1977-06-24.
- Submission: K770639
- Applicant / Sponsor: Peokin-Elmer Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2250
- Decision date: 1977-06-24
Classification & Regulation
This clearance is catalogued under FDA product code KZQ and 21 CFR 862.2250, within the Clinical Chemistry review panel as a Class I device.