The following data is part of a premarket notification filed by Dade, Baxter Travenol Diagnostics, Inc. with the FDA for Uniform Drop Size Pasteur Type Pipets.
Device ID | K760719 |
510k Number | K760719 |
Device Name: | UNIFORM DROP SIZE PASTEUR TYPE PIPETS |
Classification | Pipette, Quantitative, Hematology |
Applicant | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GJG |
CFR Regulation Number | 864.6160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-27 |
Decision Date | 1976-10-29 |