The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Varian 3300 & 3400 Gas Chromatographs.
Device ID | K841891 |
510k Number | K841891 |
Device Name: | VARIAN 3300 & 3400 GAS CHROMATOGRAPHS |
Classification | Chromatography(gas), Clinical Use |
Applicant | VARIAN ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KZQ |
CFR Regulation Number | 862.2250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-07 |
Decision Date | 1984-07-09 |