Clearance Summary
IMMUNOHEMATOLOGICAL SALINE #97139 received FDA 510(k) clearance under submission number K831200, sponsored by Emd Chemicals, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1983-05-09.
- Submission: K831200
- Applicant / Sponsor: Emd Chemicals, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1983-05-09
Classification & Regulation
This clearance is catalogued under FDA product code JCE and 21 CFR 864.4010, within the Pathology review panel as a Class I device.