Clearance Summary
ACON STREP A RAPID TEST DEVICE received FDA 510(k) clearance under submission number K031784, sponsored by ACON Laboratories, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2003-07-14.
- Submission: K031784
- Applicant / Sponsor: ACON Laboratories, Inc.
- Clearance pathway: Special
- Review panel: Microbiology
- Device class: Class I
- Regulation citation: 21 CFR 866.3740
- Decision date: 2003-07-14
Classification & Regulation
This clearance is catalogued under FDA product code GTY and 21 CFR 866.3740, within the Microbiology review panel as a Class I device.