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 |