The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Ot Igg Sorbent.
Device ID | K934324 |
510k Number | K934324 |
Device Name: | OT IGG SORBENT |
Classification | Igg, Antigen, Antiserum, Control |
Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
Contact | Ann M Quinn |
Correspondent | Ann M Quinn ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
Product Code | DEW |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-03 |
Decision Date | 1994-04-21 |