510(k) K760719
K760719 is an FDA 510(k) premarket notification submitted by Dade, Baxter Travenol Diagnostics, Inc. for the device "UNIFORM DROP SIZE PASTEUR TYPE PIPETS". The FDA issued a decision of Substantially Equivalent on October 29, 1976. The device falls under product code GJG (Pipette, Quantitative, Hematology), a Class I device regulated under 21 CFR 864.6160. Dade, Baxter Travenol Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 1976
- Date Received
- September 27, 1976
- 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