The following data is part of a premarket notification filed by Genetic Testing Institute with the FDA for Gti-fviii Inhibitor Assay.
| Device ID | K993553 |
| 510k Number | K993553 |
| Device Name: | GTI-FVIII INHIBITOR ASSAY |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | GENETIC TESTING INSTITUTE 150 NORTH PATRICK BLVD. SUITE 100 Brookfield, WI 53045 -5854 |
| Contact | Michael Moghaddam |
| Correspondent | Michael Moghaddam GENETIC TESTING INSTITUTE 150 NORTH PATRICK BLVD. SUITE 100 Brookfield, WI 53045 -5854 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-20 |
| Decision Date | 2000-02-01 |
| Summary: | summary |