The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Reagent Kit, Lancer Glucose.
Device ID | K790197 |
510k Number | K790197 |
Device Name: | REAGENT KIT, LANCER GLUCOSE |
Classification | Analyzer, Chemistry, Micro, For Clinical Use |
Applicant | SHERWOOD MEDICAL INDUSTRIES 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 | 1979-01-25 |
Decision Date | 1979-03-12 |