Clearance Summary
NUTRIENT AGAR received FDA 510(k) clearance under submission number K811138, sponsored by Acumedia Manufacturers, 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 1981-05-05.
- Submission: K811138
- Applicant / Sponsor: Acumedia Manufacturers, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2250
- Decision date: 1981-05-05
Classification & Regulation
This clearance is catalogued under FDA product code JSQ and 21 CFR 862.2250, within the Clinical Chemistry review panel as a Class I device.