FIBRINOGEN SCREEN— 510(k) K800826
Substantially EquivalentPacific Hemostasis
FDA 510(k) clearance K800826 for FIBRINOGEN SCREEN, Substantially Equivalent on 1980-05-30. Applicant: Pacific Hemostasis. Device class: 2.
Clearance details
- Applicant
- Pacific Hemostasis
- Product code
- Code KQJ
- Device class
- Class 2
- Regulation
- 21 CFR 864.7340
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code KQJ
view allMore clearances from Pacific Hemostasis
view allRecalls naming K800826
K-number listed on FDA's recall record- Z-2762-2017 — Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.
- Z-2763-2017 — Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K800826.
Data sourced from openFDA. This site is unofficial and independent of the FDA.