510(k) K771137

PIPETS UNIFORM DROP SIZE BOROSILICATE by Dade, Baxter Travenol Diagnostics, Inc. — Product Code GJW

K771137 is an FDA 510(k) premarket notification submitted by Dade, Baxter Travenol Diagnostics, Inc. for the device "PIPETS UNIFORM DROP SIZE BOROSILICATE". The FDA issued a decision of Substantially Equivalent on August 4, 1977. The device falls under product code GJW (Pipette, Pasteur), 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
August 4, 1977
Date Received
June 24, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pipette, Pasteur
Device Class
Class I
Regulation Number
864.6160
Review Panel
HE
Submission Type