The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Standards & Accessories For Nova Instru.
Device ID | K842873 |
510k Number | K842873 |
Device Name: | STANDARDS & ACCESSORIES FOR NOVA INSTRU |
Classification | Electrode, Ion Specific, Sodium |
Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JGS |
CFR Regulation Number | 862.1665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-23 |
Decision Date | 1984-10-05 |