The following data is part of a premarket notification filed by Micro Typing Systems Inc. with the FDA for Automated Blood Grouping And Antibody Test Systems.
| Device ID | BK160061 |
| 510k Number | BK160061 |
| Device Name: | Automated Blood Grouping And Antibody Test Systems |
| Classification | System, Test, Automated Blood Grouping And Antibody |
| Applicant | Micro Typing Systems Inc. 1295 S.w. 29th Ave. Pompano Beach, FL 33069 |
| Product Code | KSZ |
| CFR Regulation Number | 864.9175 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-06-28 |
| Decision Date | 2016-10-21 |