The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Spectrofluorometer Sf-330.
Device ID | K780362 |
510k Number | K780362 |
Device Name: | SPECTROFLUOROMETER SF-330 |
Classification | Fluorometer, For Clinical Use |
Applicant | VARIAN ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KHO |
CFR Regulation Number | 862.2560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-03-06 |
Decision Date | 1978-03-22 |