The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration Follow Fda En Español Search Fda Home Food Drugs Medical Devices .
| Device ID | BK100040 |
| 510k Number | BK100040 |
| Device Name: | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices |
| Classification | Multi-analyte Controls Unassayed |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 US |
| Product Code | OHQ |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-21 |
| Decision Date | 2010-07-22 |