The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Posid Sampler.
Device ID | K860508 |
510k Number | K860508 |
Device Name: | POSID SAMPLER |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | ORGANON TEKNIKA CORP. 5300 SOUTH PORTLAND AVE. Oklahoma City, OK 73119 |
Contact | Robert D Wurzel |
Correspondent | Robert D Wurzel ORGANON TEKNIKA CORP. 5300 SOUTH PORTLAND AVE. Oklahoma City, OK 73119 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-11 |
Decision Date | 1986-05-02 |