510(k) K843073
K843073 is an FDA 510(k) premarket notification submitted by Greene International Corp. for the device "FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP". The FDA issued a decision of Substantially Equivalent on August 24, 1984. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Greene International Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1984
- Date Received
- August 6, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Station, Pipetting And Diluting, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2750
- Review Panel
- CH
- Submission Type