The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Diastat Anti-thyroglobulin Kit.
Device ID | K952183 |
510k Number | K952183 |
Device Name: | DIASTAT ANTI-THYROGLOBULIN KIT |
Classification | System, Test, Thyroid Autoantibody |
Applicant | SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
Contact | Eileen A Mccafferty |
Correspondent | Eileen A Mccafferty SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, GB Dd2 1sw |
Product Code | JZO |
CFR Regulation Number | 866.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-09 |
Decision Date | 1995-06-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847817016271 | K952183 | 000 |
07340058410110 | K952183 | 000 |