The following data is part of a premarket notification filed by Immuno Probe, Inc. with the FDA for Mycoplasma Igg Elisa Test System.
| Device ID | K971393 |
| 510k Number | K971393 |
| Device Name: | MYCOPLASMA IGG ELISA TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. |
| Applicant | IMMUNO PROBE, INC. 1306F BAILES LN. Frederick, MD 21701 |
| Contact | William L Boteler |
| Correspondent | William L Boteler IMMUNO PROBE, INC. 1306F BAILES LN. Frederick, MD 21701 |
| Product Code | LJZ |
| CFR Regulation Number | 866.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-09 |
| Decision Date | 1997-07-14 |
| Summary: | summary |