The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Standard & Solutions For Nova 4 Analyz.
Device ID | K843452 |
510k Number | K843452 |
Device Name: | STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ |
Classification | Electrode, Ion Specific, Sodium |
Applicant | FISHER SCIENTIFIC CO., LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JGS |
CFR Regulation Number | 862.1665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-05 |
Decision Date | 1984-09-27 |