The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Legionella Elisa Test System.
| Device ID | K970149 |
| 510k Number | K970149 |
| Device Name: | LEGIONELLA ELISA TEST SYSTEM |
| Classification | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Mark J Kepnitsky |
| Correspondent | Mark J Kepnitsky ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | LHL |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-15 |
| Decision Date | 1997-06-18 |