The following data is part of a premarket notification filed by Genetic Testing Institute with the FDA for Pf4 Enhanced Solid Phase Elisa.
| Device ID | K053559 |
| 510k Number | K053559 |
| Device Name: | PF4 ENHANCED SOLID PHASE ELISA |
| Classification | Platelet Factor 4 Radioimmunoassay |
| Applicant | GENETIC TESTING INSTITUTE 20925 CROSSROADS CIRCLE SUITE 200 Waukesha, WI 53186 -4054 |
| Contact | Leigh Ann Tidey |
| Correspondent | Leigh Ann Tidey GENETIC TESTING INSTITUTE 20925 CROSSROADS CIRCLE SUITE 200 Waukesha, WI 53186 -4054 |
| Product Code | LCO |
| CFR Regulation Number | 864.7695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-21 |
| Decision Date | 2006-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234500438 | K053559 | 000 |
| 10888234500421 | K053559 | 000 |
| 10888234500414 | K053559 | 000 |
| 10888234500391 | K053559 | 000 |
| 10888234500353 | K053559 | 000 |
| 10888234500032 | K053559 | 000 |
| 10888234500025 | K053559 | 000 |