The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Ena Profile-6 Elisa Test System.
| Device ID | K941409 |
| 510k Number | K941409 |
| Device Name: | ENA PROFILE-6 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 | 1994-03-23 |
| Decision Date | 1994-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239027863 | K941409 | 000 |
| 04048474027822 | K941409 | 000 |
| 04048474027839 | K941409 | 000 |
| 04048474027846 | K941409 | 000 |
| 04048474027853 | K941409 | 000 |
| 04048474027860 | K941409 | 000 |
| 04048474027877 | K941409 | 000 |
| 00840239027870 | K941409 | 000 |
| 00840239027801 | K941409 | 000 |
| 00840239027825 | K941409 | 000 |
| 00840239027832 | K941409 | 000 |
| 00840239027849 | K941409 | 000 |
| 00840239027856 | K941409 | 000 |
| 04048474027808 | K941409 | 000 |