Clearance Summary
SYSTEM WASHER 100 received FDA 510(k) clearance under submission number K936258, sponsored by Eg&G Berthold. 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 1994-04-26.
- Submission: K936258
- Applicant / Sponsor: Eg&G Berthold
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2750
- Decision date: 1994-04-26
Classification & Regulation
This clearance is catalogued under FDA product code JQW and 21 CFR 862.2750, within the Clinical Chemistry review panel as a Class I device.