The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Pmk Primary Monkey Kidney-cells.
| Device ID | K842833 |
| 510k Number | K842833 |
| Device Name: | PMK PRIMARY MONKEY KIDNEY-CELLS |
| Classification | Erythrosin B |
| Applicant | BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KJR |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-20 |
| Decision Date | 1984-08-28 |