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510(k) K010750

PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 by Fisher Diagnostics — Product Code GGN

K010750 is an FDA 510(k) premarket notification submitted by Fisher Diagnostics for the device "PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560". The FDA issued a decision of Substantially Equivalent on September 7, 2001. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Fisher Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2001
Date Received
March 13, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Control
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Fisher Diagnostics

  • K170652 — ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R (June 1, 2017)
  • K070640 — ARCHITECT STAT TROPONIN-1; MYOGLOBIN (September 13, 2007)
  • K052407 — ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS (July 18, 2006)
  • K052308 — ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY C (May 10, 2006)
  • K042924 — ARCHITECT STAT MYO IMMUNOASSAY (January 24, 2005)
  • K041192 — ARCHITECT STAT TROPONIN-I IMMUNOASSAY (August 12, 2004)
  • K041596 — ARCHITECT STAT CK-MB IMMUNOASSAY (July 21, 2004)
  • K023362 — FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLU (December 9, 2002)
  • K013397 — PACIFIC HEMOSTASIS REFERENCE EMULSION (February 15, 2002)
  • K850160 — FISHER DIAGNOSTICS LATEST-CRP TEST KIT (April 19, 1985)

Other clearances for product code GGN

  • K170864 — VALIDATE D-Dimer Calibration Verification / Linearity Test Kit (June 21, 2017)
  • K163498 — VALIDATE Heparin Calibration Verification/Linearity Test Kit (March 16, 2017)
  • K161316 — George King Coumadin Plasma (February 23, 2017)
  • K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit (January 5, 2017)
  • K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (June 3, 2016)
  • K150144 — VisuCon-F Low Fibrinogen Control Plasma (March 6, 2016)
  • K142132 — POOL NORM (December 12, 2014)
  • K133582 — HEMOSIL D-DIMER HS 500 CONTROL (August 15, 2014)
  • K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DI (July 3, 2013)
  • K120900 — I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 (May 31, 2013)

FDA data resources