The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Primary Rabbitt Kidney Cell Culture.
Device ID | K842000 |
510k Number | K842000 |
Device Name: | PRIMARY RABBITT KIDNEY CELL CULTURE |
Classification | Cells, Animal And Human, Cultured |
Applicant | BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KIR |
CFR Regulation Number | 864.2280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-16 |
Decision Date | 1984-06-22 |