The following data is part of a premarket notification filed by Interscience, Inc. with the FDA for Blood Cell Diluent 78n 1913.
Device ID | K822325 |
510k Number | K822325 |
Device Name: | BLOOD CELL DILUENT 78N 1913 |
Classification | Diluent, Blood Cell |
Applicant | INTERSCIENCE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GIF |
CFR Regulation Number | 864.8200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-03 |
Decision Date | 1982-10-18 |