The following data is part of a premarket notification filed by Diatech Diagnostica Ltd. with the FDA for Diatech Igm-mp Test.
| Device ID | K895276 |
| 510k Number | K895276 |
| Device Name: | DIATECH IGM-MP TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. |
| Applicant | DIATECH DIAGNOSTICA LTD. SCIENCE PARK, KIRYAT WEIZMANN REHOVOT 76326 Israel, IL |
| Contact | Hana Gadassi |
| Correspondent | Hana Gadassi DIATECH DIAGNOSTICA LTD. SCIENCE PARK, KIRYAT WEIZMANN REHOVOT 76326 Israel, IL |
| Product Code | LJZ |
| CFR Regulation Number | 866.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-23 |
| Decision Date | 1989-12-18 |