510(k) K971640
K971640 is an FDA 510(k) premarket notification submitted by Esa, Inc. for the device "LEADCARE BLOOD LEAD TESTING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 9, 1997. The device falls under product code DOF (Lead, Atomic Absorption), a Class II device regulated under 21 CFR 862.3550. Esa, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1997
- Date Received
- May 2, 1997
- Clearance Type
- Traditional
- 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