Clearance Summary
FITKIT I CHECKUP KIT received FDA 510(k) clearance under submission number K821799, sponsored by Patton, Boggs & Blow. 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 1983-08-16.
- Submission: K821799
- Applicant / Sponsor: Patton, Boggs & Blow
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1785
- Decision date: 1983-08-16
Classification & Regulation
This clearance is catalogued under FDA product code CDM and 21 CFR 862.1785, within the Clinical Chemistry review panel as a Class I device.