The following data is part of a premarket notification filed by Genetic Testing Institute with the FDA for Gti-pf4 Elisa.
| Device ID | K983379 |
| 510k Number | K983379 |
| Device Name: | GTI-PF4 ELISA |
| Classification | Platelet Factor 4 Radioimmunoassay |
| 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 | LCO |
| CFR Regulation Number | 864.7695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-25 |
| Decision Date | 1999-03-09 |