Clearance Summary
IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST received FDA 510(k) clearance under submission number K921968, sponsored by Tech-Co, 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 1996-06-28.
- Submission: K921968
- Applicant / Sponsor: Tech-Co, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 1996-06-28
Classification & Regulation
This clearance is catalogued under FDA product code JHJ and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.