The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Imr-90-diploid-human Fetal Lung Cell.
| Device ID | K841998 |
| 510k Number | K841998 |
| Device Name: | IMR-90-DIPLOID-HUMAN FETAL LUNG CELL |
| 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 | 1984-06-27 |