510(k) K831079
K831079 is an FDA 510(k) premarket notification submitted by The Kendall Company Div. of Tyco Healthcare Group for the device "LIQUIPETTE". The FDA issued a decision of Substantially Equivalent on April 28, 1983. The device falls under product code GJG (Pipette, Quantitative, Hematology), a Class I device regulated under 21 CFR 864.6160. The Kendall Company Div. of Tyco Healthcare Group has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 1983
- Date Received
- April 4, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pipette, Quantitative, Hematology
- Device Class
- Class I
- Regulation Number
- 864.6160
- Review Panel
- HE
- Submission Type