PF4 IGG
Platelet Factor 4 Radioimmunoassay
GENETIC TESTING INSTITUTE
The following data is part of a premarket notification filed by Genetic Testing Institute with the FDA for Pf4 Igg.
Pre-market Notification Details
| Device ID | K071781 |
| 510k Number | K071781 |
| Device Name: | PF4 IGG |
| Classification | Platelet Factor 4 Radioimmunoassay |
| Applicant | GENETIC TESTING INSTITUTE 20925 CROSSROADS CIRCLE SUITE 200 Waukesha, WI 53186 -4054 |
| Contact | Suzette C Chance |
| Correspondent | Suzette C Chance 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-02 |
| Decision Date | 2007-12-19 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234500384 | K071781 | 000 |
| 10888234500056 | K071781 | 000 |
| 10888234500049 | K071781 | 000 |
Trademark Results [PF4 IGG]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PF4 IGG 77129308 not registered Dead/Abandoned |
Genetic Testing Institute, Inc. 2007-03-13 |
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