The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Zeus Ifa Ana Hep-2 Test System, Zeus Difine.
| Device ID | K201956 |
| 510k Number | K201956 |
| Device Name: | Zeus IFA ANA HEp-2 Test System, Zeus DIFine |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | Zeus Scientific, Inc. PO Box 38 Raritan, NJ 08869 |
| Contact | Mark J. Kopnitsky |
| Correspondent | Mark J. Kopnitsky Zeus Scientific, Inc. PO Box 38 Raritan, NJ 08869 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-14 |
| Decision Date | 2022-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08059304340109 | K201956 | 000 |