510(k) K042322
K042322 is an FDA 510(k) premarket notification submitted by Hach Company for the device "STERICHEK BLOOD LEAK REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on December 7, 2004. The device falls under product code FJD (Detector, Leak, Blood), a Class II device regulated under 21 CFR 876.5820. Hach Company has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 2004
- Date Received
- August 26, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector, Leak, Blood
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type