The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Mycoplasma Igm Elisa Test System.
| Device ID | K971503 |
| 510k Number | K971503 |
| Device Name: | MYCOPLASMA IGM ELISA TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. |
| Applicant | ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Contact | Mark J Kopnitsky |
| Correspondent | Mark J Kopnitsky ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Product Code | LJZ |
| CFR Regulation Number | 866.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-24 |
| Decision Date | 1997-08-20 |