The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Distat Anti-dsdna Kit.
| Device ID | K905386 |
| 510k Number | K905386 |
| Device Name: | DISTAT ANTI-DSDNA KIT |
| Classification | Anti-dna Indirect Immunofluorescent Solid Phase |
| Applicant | SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
| Contact | George Zajicek |
| Correspondent | George Zajicek SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
| Product Code | KTL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-30 |
| Decision Date | 1990-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817016240 | K905386 | 000 |
| 07340058410035 | K905386 | 000 |