The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Distat Anti-scl-70 Kit.
| Device ID | K912291 |
| 510k Number | K912291 |
| Device Name: | DISTAT ANTI-SCL-70 KIT |
| Classification | Antinuclear Antibody, Antigen, Control |
| 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 | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-23 |
| Decision Date | 1991-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07340058410462 | K912291 | 000 |