The following data is part of a premarket notification filed by Fisher Diagnostics with the FDA for Pacific Hemostasis Reference Emulsion.
| Device ID | K013397 |
| 510k Number | K013397 |
| Device Name: | PACIFIC HEMOSTASIS REFERENCE EMULSION |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | FISHER DIAGNOSTICS 8365 VALLEY PIKE Middletown, VA 22645 -0307 |
| Contact | Jerald P Steiner |
| Correspondent | Jerald P Steiner FISHER DIAGNOSTICS 8365 VALLEY PIKE Middletown, VA 22645 -0307 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-15 |
| Decision Date | 2002-02-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275000719 | K013397 | 000 |