The following data is part of a premarket notification filed by Laboratory Products, Inc. with the FDA for Flame Photometry Reagents.
Device ID | K803051 |
510k Number | K803051 |
Device Name: | FLAME PHOTOMETRY REAGENTS |
Classification | Calibrator, Multi-analyte Mixture |
Applicant | LABORATORY PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-12-02 |
Decision Date | 1981-01-09 |