The following data is part of a premarket notification filed by R2 Diagnostics, Inc. with the FDA for Thrombo Tek Pse, Model 90-480.
| Device ID | K082631 |
| 510k Number | K082631 |
| Device Name: | THROMBO TEK PSE, MODEL 90-480 |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | R2 DIAGNOSTICS, INC. 1801 COMMERCE DR. South Bend, IN 46628 |
| Contact | Marc D Goldford |
| Correspondent | Marc D Goldford R2 DIAGNOSTICS, INC. 1801 COMMERCE DR. South Bend, IN 46628 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-10 |
| Decision Date | 2008-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859394006095 | K082631 | 000 |