The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for The Aptus (automated) Application Of The Mycoplasma Igm Elisa Test System..
| Device ID | K984153 |
| 510k Number | K984153 |
| Device Name: | THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. |
| Classification | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. |
| 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 | LJZ |
| CFR Regulation Number | 866.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-19 |
| Decision Date | 1999-01-11 |