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510(k) K102908

NOFACT IX by R2 Diagnostics, Inc. — Product Code GJT

K102908 is an FDA 510(k) premarket notification submitted by R2 Diagnostics, Inc. for the device "NOFACT IX". The FDA issued a decision of Substantially Equivalent on Dec 19, 2011. The device falls under product code GJT (Plasma, Coagulation Factor Deficient), a Class II device regulated under 21 CFR 864.7290. R2 Diagnostics, Inc. has 9 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 19, 2011
Date Received
Oct 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Plasma, Coagulation Factor Deficient
Device Class
Class II
Regulation Number
864.7290
Review Panel
HE
Submission Type
510(k)

Other clearances by R2 Diagnostics, Inc.

  • K102851 — NOFACT VIII (Dec 19, 2011)
  • K090105 — LUPOTEK KCT (Dec 30, 2010)
  • K083878 — LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA (Jun 25, 2010)
  • K082631 — THROMBO TEK PSE, MODEL 90-480 (Dec 17, 2008)
  • K062306 — PLASMACON N, PLASMACON L-1, PLASMACON L-2 (Mar 16, 2007)
  • K050817 — T-TEK (Dec 12, 2005)
  • K042919 — FIBROTEK FIB (Nov 29, 2004)
  • K040296 — PHOSPHOPLASTIN RL (May 24, 2004)
  • K033471 — PHOSPHOLIN ES AND CALCIUM CHLORIDE (Feb 4, 2004)

Other clearances for product code GJT

  • K222831 — CRYOcheck Factor VIII Deficient Plasma with VWF (Sep 13, 2023)
  • K180486 — HemosIL Factor XII Deficient Plasma (Mar 22, 2018)
  • K102851 — NOFACT VIII (Dec 19, 2011)
  • K110237 — HEMOSIL FACTOR VIII DEFICIENT PLASMA (Jul 8, 2011)
  • K050661 — HEMOSIL FACTOR II DEFICIENT PLASMA (May 2, 2005)
  • K043459 — HEMOSIL FACTOR XII DEFICIENT PLASMA (Feb 9, 2005)
  • K040362 — DIAPHARMA FACTOR X KIT (Jul 12, 2004)
  • K034007 — HEMOSIL FACTOR VIII DEFICIENT PLASMA (Feb 13, 2004)
  • K031829 — HEMOSIL FACTOR IX DEFICIENT PLASMA (Jul 31, 2003)
  • K031122 — HEMOSIL FACTOR X DEFICIENT PLASMA (May 19, 2003)

FDA data resources

Source: FDA 510(k) database entry for K102908. Report a data issue: hello@regdatalab.com.