The following data is part of a premarket notification filed by Fisher Diagnostics with the FDA for Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus Kaolin.
| Device ID | K023362 |
| 510k Number | K023362 |
| Device Name: | FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN |
| Classification | Instrument, Coagulation, Automated |
| Applicant | FISHER DIAGNOSTICS 8365 VALLEY PIKE Middletown, VA 22645 -0307 |
| Contact | Jerald Steiner |
| Correspondent | Jerald Steiner FISHER DIAGNOSTICS 8365 VALLEY PIKE Middletown, VA 22645 -0307 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-07 |
| Decision Date | 2002-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275000825 | K023362 | 000 |