The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Diastat Anti-mitochondrial Antibody Kit.
| Device ID | K921183 |
| 510k Number | K921183 |
| Device Name: | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT |
| Classification | Antimitochondrial Antibody, Indirect Immunofluorescent, 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 | DBM |
| CFR Regulation Number | 866.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-09 |
| Decision Date | 1992-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817016257 | K921183 | 000 |
| 07340058410417 | K921183 | 000 |