The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Astra Printer Paper #88112-chloride Silv.
Device ID | K802392 |
510k Number | K802392 |
Device Name: | ASTRA PRINTER PAPER #88112-CHLORIDE SILV |
Classification | Analyzer, Chemistry, Micro, For Clinical Use |
Applicant | HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJF |
CFR Regulation Number | 862.2170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-02 |
Decision Date | 1980-10-23 |