510(k) K936060
K936060 is an FDA 510(k) premarket notification submitted by Thermo Jarrell Ash Corp.Div.Thermo Inst. for the device "ATOMSPEC GF BLOOD LEAD WORKSTATION". The FDA issued a decision of Substantially Equivalent on September 6, 1994. The device falls under product code DOF (Lead, Atomic Absorption), a Class II device regulated under 21 CFR 862.3550.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 1994
- Date Received
- December 20, 1993
- 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