The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Diastat Anti-sm.
| Device ID | K905191 |
| 510k Number | K905191 |
| Device Name: | DIASTAT ANTI-SM |
| Classification | Anti-sm Antibody, Antigen And Control |
| Applicant | SHIELD DIAGNOSTICS, LTD. TECHNOLOGY PARK DUNDEE DD2 1SW Scotland, KN 77359 |
| Contact | George Zajicek |
| Correspondent | George Zajicek SHIELD DIAGNOSTICS, LTD. TECHNOLOGY PARK DUNDEE DD2 1SW Scotland, KN 77359 |
| Product Code | LKP |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-19 |
| Decision Date | 1990-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07340058410059 | K905191 | 000 |