Clearance Summary
GAMMA GLUTAMYL TRANSFERASE REAGENT SET received FDA 510(k) clearance under submission number K881239, sponsored by Tech-Neal Scientific, 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 1988-05-31.
- Submission: K881239
- Applicant / Sponsor: Tech-Neal Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1360
- Decision date: 1988-05-31
Classification & Regulation
This clearance is catalogued under FDA product code JPZ and 21 CFR 862.1360, within the Clinical Chemistry review panel as a Class I device.