The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Multianalyte Controls, All Kinds.
Device ID | K811182 |
510k Number | K811182 |
Device Name: | MULTIANALYTE CONTROLS, ALL KINDS |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | FISHER SCIENTIFIC CO., LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-28 |
Decision Date | 1981-05-15 |