Clearance Summary
ANALOX LM3 MICRO-STAT ANALYSER received FDA 510(k) clearance under submission number K843082, sponsored by Analox Instruments , Ltd.. 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 1984-10-17.
- Submission: K843082
- Applicant / Sponsor: Analox Instruments , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2160
- Decision date: 1984-10-17
Classification & Regulation
This clearance is catalogued under FDA product code JJE and 21 CFR 862.2160, within the Clinical Chemistry review panel as a Class I device.