The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Lancer Analyzer Cups.
Device ID | K833157 |
510k Number | K833157 |
Device Name: | LANCER ANALYZER CUPS |
Classification | Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use |
Applicant | SHERWOOD MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJC |
CFR Regulation Number | 862.2150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-16 |
Decision Date | 1983-12-08 |