The following data is part of a premarket notification filed by Axis-shield Diagnostics, Ltd. with the FDA for Axis-shield Liquid Stable (ls) 2-part Homocysteine Reagent, Model Fhrk100.
| Device ID | K083222 |
| 510k Number | K083222 |
| Device Name: | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| Applicant | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland, GB Dd2 1xa |
| Contact | Claire Dora |
| Correspondent | Claire Dora AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland, GB Dd2 1xa |
| Product Code | LPS |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-03 |
| Decision Date | 2009-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014573 | K083222 | 000 |
| 00817439020918 | K083222 | 000 |
| 05055845400282 | K083222 | 000 |
| 05055845400183 | K083222 | 000 |
| 05055845400176 | K083222 | 000 |
| 05055845400169 | K083222 | 000 |
| 05055273208894 | K083222 | 000 |
| 00811727015877 | K083222 | 000 |