510(k) K052549
K052549 is an FDA 510(k) premarket notification submitted by Esa Biosciences, Inc. for the device "LEADCARE II BLOOD LEAD TESTING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 6, 2005. The device falls under product code DOF (Lead, Atomic Absorption), a Class II device regulated under 21 CFR 862.3550. Esa Biosciences, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 2005
- Date Received
- September 16, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lead, Atomic Absorption
- Device Class
- Class II
- Regulation Number
- 862.3550
- Review Panel
- TX
- Submission Type