The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Calibrator No. 1 & 2, & Wash Solution.
Device ID | K800220 |
510k Number | K800220 |
Device Name: | CALIBRATOR NO. 1 & 2, & WASH SOLUTION |
Classification | Calibrator, Secondary |
Applicant | FISHER SCIENTIFIC CO., LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JIT |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-04 |
Decision Date | 1980-02-26 |