The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Modification To Zeus Scientific, Inc., Thyroglobulin Igg Elisa Test System.
Device ID | K000363 |
510k Number | K000363 |
Device Name: | MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM |
Classification | Thyroglobulin, Antigen, Antiserum, Control |
Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
Contact | Mark J Kopnitsky |
Correspondent | Mark J Kopnitsky ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
Product Code | DDC |
CFR Regulation Number | 866.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-04 |
Decision Date | 2000-02-18 |