The following data is part of a premarket notification filed by Dade, Baxter Travenol Diagnostics, Inc. with the FDA for Flurometer, Dade.
Device ID | K782150 |
510k Number | K782150 |
Device Name: | FLUROMETER, DADE |
Classification | Fluorometer |
Applicant | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JZT |
CFR Regulation Number | 866.4520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-26 |
Decision Date | 1979-02-15 |