Clearance Summary
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD received FDA 510(k) clearance under submission number K003696, sponsored by Dade Behring, 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 2001-01-25.
- Submission: K003696
- Applicant / Sponsor: Dade Behring, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 2001-01-25
Classification & Regulation
This clearance is catalogued under FDA product code DHA and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.