FDA 510(k) Applications Submitted by Antoinette Prusik
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K163225 | 11/17/2016 | AFIAS iFOB with AFIAS-50 | IMMUNOSTICS, INC. |
| K163465 | 12/12/2016 | hemochroma PLUS System | IMMUNOSTICS, INC. |
| K163554 | 12/19/2016 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test | Immunostics, Inc. |
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