The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il Phoenix, Model 900, Chemistry/electrolyte Analy.
Device ID | K884771 |
510k Number | K884771 |
Device Name: | IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY |
Classification | Electrode, Ion Specific, Calcium |
Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. P.O. BOX 9113 Lexington, MA 02173 |
Contact | George A Lyna |
Correspondent | George A Lyna INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. P.O. BOX 9113 Lexington, MA 02173 |
Product Code | JFP |
CFR Regulation Number | 862.1145 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-14 |
Decision Date | 1989-02-10 |