The following data is part of a premarket notification filed by Abaxis, Inc. with the FDA for Piccolo C-reactive Protein (crp) Test System.
| Device ID | K091052 |
| 510k Number | K091052 |
| Device Name: | PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM |
| Classification | System, Test, C-reactive Protein |
| Applicant | ABAXIS, INC. 3240 WHIPPLE RD. Union City, CA 94587 |
| Contact | Dennis M Bleile |
| Correspondent | Dennis M Bleile ABAXIS, INC. 3240 WHIPPLE RD. Union City, CA 94587 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-13 |
| Decision Date | 2010-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EABA40000411 | K091052 | 000 |