The following data is part of a premarket notification filed by Axis-shield Diagnostics, Ltd. with the FDA for Abbott Axsym B-type Natriuretic Peptide (bnp) Microparticle Enzyme Immunoassay (meia) Test.
| Device ID | K033606 |
| 510k Number | K033606 |
| Device Name: | ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST |
| Classification | Test, Natriuretic Peptide |
| Applicant | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK LUNA PLACE Dundee, Scotland, GB Dd2 1xa |
| Contact | Judith Finlayson, Ph.d. |
| Correspondent | Judith Finlayson, Ph.d. AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK LUNA PLACE Dundee, Scotland, GB Dd2 1xa |
| Product Code | NBC |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-17 |
| Decision Date | 2004-01-30 |
| Summary: | summary |