510(k) K760719

UNIFORM DROP SIZE PASTEUR TYPE PIPETS by Dade, Baxter Travenol Diagnostics, Inc. — Product Code GJG

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