The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Ena Screen Elisa Test System.
| Device ID | K941014 |
| 510k Number | K941014 |
| Device Name: | ENA SCREEN ELISA TEST SYSTEM |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| 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 | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-03 |
| Decision Date | 1994-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239027795 | K941014 | 000 |
| 04048474027792 | K941014 | 000 |