FDA Product Code JEJ: Tubing, Instrumentation, Bronchoscope (brush Sheath A/o Aspirating)
If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
Leading manufacturers include Technicon Instruments Corp. and Em Diagnostic Systems, Inc..
2
Total
2
Cleared
17d
Avg days
1982
Since
FDA 510(k) Cleared Tubing, Instrumentation, Bronchoscope (brush Sheath A/o Aspirating) Devices (Product Code JEJ)
2 devices
Cleared
Dec 22, 1987
EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019
Em Diagnostic Systems, Inc.
Chemistry
33d
Cleared
May 10, 1982
TECHNICON RA-1000 SYS, ANALYTES III
Technicon Instruments Corp.
Chemistry