The following data is part of a premarket notification filed by Cambridge Diagnostics Ireland, Ltd. with the FDA for Human Lyme Igm Western Blot Kit.
| Device ID | K970768 |
| 510k Number | K970768 |
| Device Name: | HUMAN LYME IGM WESTERN BLOT KIT |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | CAMBRIDGE DIAGNOSTICS IRELAND, LTD. MERVUE BUSINESS PARK Galway, IE |
| Contact | Sile Macmahon |
| Correspondent | Sile Macmahon CAMBRIDGE DIAGNOSTICS IRELAND, LTD. MERVUE BUSINESS PARK Galway, IE |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-03 |
| Decision Date | 1998-04-09 |