The following data is part of a premarket notification filed by Immunodiagnostics, Ltd. with the FDA for The Gamma-b Anti-ds Dna Kit & Optional Controls.
| Device ID | K872085 |
| 510k Number | K872085 |
| Device Name: | THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS |
| Classification | Anti-dna Antibody, Antigen And Control |
| Applicant | IMMUNODIAGNOSTICS, LTD. DISTRICT 12, WASHINGTON TYNE & WEAR England, U.k., GB Ne373hs |
| Contact | Hayden Jeffery |
| Correspondent | Hayden Jeffery IMMUNODIAGNOSTICS, LTD. DISTRICT 12, WASHINGTON TYNE & WEAR England, U.k., GB Ne373hs |
| Product Code | LSW |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-01 |
| Decision Date | 1987-09-01 |