The following data is part of a premarket notification filed by Diatech Diagnostica Ltd. with the FDA for Mp Test.
| Device ID | K882596 |
| 510k Number | K882596 |
| Device Name: | MP TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. |
| Applicant | DIATECH DIAGNOSTICA LTD. 1120 VERMONT AVE., N.W. SUITE 600 Washington, DC 20005 |
| Contact | Mackler, Phd |
| Correspondent | Mackler, Phd DIATECH DIAGNOSTICA LTD. 1120 VERMONT AVE., N.W. SUITE 600 Washington, DC 20005 |
| Product Code | LJZ |
| CFR Regulation Number | 866.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-24 |
| Decision Date | 1989-06-21 |