The following data is part of a premarket notification filed by Fisher Diagnostics with the FDA for Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560.
| Device ID | K010750 |
| 510k Number | K010750 |
| Device Name: | PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 |
| Classification | Plasma, Coagulation Control |
| Applicant | FISHER DIAGNOSTICS 8365 VALLEY PIKE Middletown, VA 22645 -0307 |
| Contact | Nadia Greenidge |
| Correspondent | Nadia Greenidge FISHER DIAGNOSTICS 8365 VALLEY PIKE Middletown, VA 22645 -0307 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-13 |
| Decision Date | 2001-09-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275000818 | K010750 | 000 |