The following data is part of a premarket notification filed by Waters Assoc., Inc. with the FDA for Cartridge Holder, Rcm 100.
Device ID | K782175 |
510k Number | K782175 |
Device Name: | CARTRIDGE HOLDER, RCM 100 |
Classification | Apparatus, High Pressure Liquid Chromatography |
Applicant | WATERS ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KIE |
CFR Regulation Number | 862.2260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-28 |
Decision Date | 1979-02-15 |