The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Automated Bloodborne Pathogen Test Equipment.
| Device ID | BK130006 |
| 510k Number | BK130006 |
| Device Name: | Automated Bloodborne Pathogen Test Equipment |
| Classification | Test, Equipment, Automated Bloodborne Pathogen |
| Applicant | Ortho-Clinical Diagnostics, Inc. 1001 U.s. Highway 202 Raritan, NJ 08869 US |
| Product Code | MZA |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-25 |
| Decision Date | 2013-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750012763 | BK130006 | 0 |
| 10758750005451 | BK130006 | 0 |
| 10758750005581 | BK130006 | 0 |
| 10758750007523 | BK130006 | 0 |
| 10758750011582 | BK130006 | 0 |
| 10758750011599 | BK130006 | 0 |
| 10758750013265 | BK130006 | 0 |
| 10758750005482 | BK130006 | 0 |
| 10758750005499 | BK130006 | 0 |
| 10758750005505 | BK130006 | 0 |
| 10758750005420 | BK130006 | 0 |