Clearance Summary
ULTRAZYME PLUS GAMMA-GT, #64959/65032 received FDA 510(k) clearance under submission number K823883, sponsored by Emd Chemicals, 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 1983-01-28.
- Submission: K823883
- Applicant / Sponsor: Emd Chemicals, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1360
- Decision date: 1983-01-28
Classification & Regulation
This clearance is catalogued under FDA product code JQB and 21 CFR 862.1360, within the Clinical Chemistry review panel as a Class I device.