The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash B2gp1-domain1, Quanta Flash B2gp1-domain1 Controls, Hemosil Acustar Anti-b2gpi Domain 1, Hemosil Acustar Anti-b2gpi Domain 1 Controls.
| Device ID | K152875 |
| 510k Number | K152875 |
| Device Name: | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls |
| Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD San Diego, CA 92131 -1638 |
| Contact | Gabriella Lakos |
| Correspondent | Gabriella Lakos INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD San Diego, CA 92131 -1638 |
| Product Code | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-30 |
| Decision Date | 2015-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426951298778 | K152875 | 000 |
| 08426951301706 | K152875 | 000 |
| 08426950601951 | K152875 | 000 |