Clearance Summary
CK/LD ISOENZYME CONTROL PROD. #ACS CT101 received FDA 510(k) clearance under submission number K800370, sponsored by Analytical Control Systems, 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 1980-03-12.
- Submission: K800370
- Applicant / Sponsor: Analytical Control Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1980-03-12
Classification & Regulation
This clearance is catalogued under FDA product code JJY and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.