The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Serum, Potassium Determination Of.
Device ID | K790018 |
510k Number | K790018 |
Device Name: | SERUM, POTASSIUM DETERMINATION OF |
Classification | Electrode, Ion Specific, Potassium |
Applicant | FISHER SCIENTIFIC CO., LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CEM |
CFR Regulation Number | 862.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-03 |
Decision Date | 1979-02-01 |