The following data is part of a premarket notification filed by Zeus Technologies with the FDA for Veri-staph.
Device ID | K830783 |
510k Number | K830783 |
Device Name: | VERI-STAPH |
Classification | Kit, Screening, Staphylococcus Aureus |
Applicant | ZEUS TECHNOLOGIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JWX |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-11 |
Decision Date | 1983-04-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816057021840 | K830783 | 000 |
00816057021833 | K830783 | 000 |
00816057021826 | K830783 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VERI-STAPH 73437704 1293634 Dead/Cancelled |
Zeus Technologies, Inc. 1983-08-04 |