510(k) K843839
K843839 is an FDA 510(k) premarket notification submitted by Tri-Tech, Inc. for the device "STAT/PB REAGENT". The FDA issued a decision of Substantially Equivalent on January 3, 1985. The device falls under product code DOF (Lead, Atomic Absorption), a Class II device regulated under 21 CFR 862.3550. Tri-Tech, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 1985
- Date Received
- October 1, 1984
- 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