The following data is part of a premarket notification filed by Laboratory Data Control with the FDA for Ldc Spectromonitor Iii.
Device ID | K800289 |
510k Number | K800289 |
Device Name: | LDC SPECTROMONITOR III |
Classification | Apparatus, High Pressure Liquid Chromatography |
Applicant | LABORATORY DATA CONTROL 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 | 1980-02-11 |
Decision Date | 1980-02-26 |