PMK PRIMARY MONKEY KIDNEY-CELLS

Erythrosin B

BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC.

The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Pmk Primary Monkey Kidney-cells.

Pre-market Notification Details

Device IDK842833
510k NumberK842833
Device Name:PMK PRIMARY MONKEY KIDNEY-CELLS
ClassificationErythrosin B
Applicant BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKJR  
CFR Regulation Number864.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-20
Decision Date1984-08-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.