The following data is part of a premarket notification filed by Genetic Testing Institute with the FDA for Factor Viii Antibody Screen.
| Device ID | K082205 |
| 510k Number | K082205 |
| Device Name: | FACTOR VIII ANTIBODY SCREEN |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | GENETIC TESTING INSTITUTE 20925 CROSSROADS CIRCLE SUITE 200 Waukesha, WI 53186 -4054 |
| Contact | Michelle A Stapleton |
| Correspondent | Michelle A Stapleton GENETIC TESTING INSTITUTE 20925 CROSSROADS CIRCLE SUITE 200 Waukesha, WI 53186 -4054 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-05 |
| Decision Date | 2008-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234500346 | K082205 | 000 |
| 10888234500339 | K082205 | 000 |
| 10888234500322 | K082205 | 000 |
| 10888234500001 | K082205 | 000 |