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510(k) K032804

CRYOCHECK WEAK LUPUS POSITIVE CONTROL by Precision Biologic — Product Code GGC

K032804 is an FDA 510(k) premarket notification submitted by Precision Biologic for the device "CRYOCHECK WEAK LUPUS POSITIVE CONTROL". The FDA issued a decision of Substantially Equivalent on November 3, 2003. The device falls under product code GGC (Control, Plasma, Abnormal), a Class II device regulated under 21 CFR 864.5425. Precision Biologic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2003
Date Received
September 9, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Precision Biologic

  • K251440 — CRYOcheck Chromogenic Factor VIII (August 25, 2025)
  • K222831 — CRYOcheck Factor VIII Deficient Plasma with VWF (September 13, 2023)
  • K214002 — CRYOcheck Chromogenic Factor IX (December 23, 2022)
  • K193556 — Cryocheck Hex LA (October 23, 2020)
  • K193204 — Cryocheck Chromogenic Factor VIII (July 17, 2020)
  • K183440 — CRYOcheck FVIII Inhibitor Kit (March 12, 2019)
  • K060284 — CRYOCHECK CLOT APCR (May 10, 2006)
  • K043571 — CRYOCHECK CLOT S (March 18, 2005)
  • K040987 — CRYOCHECK CLOT C (June 18, 2004)
  • K023991 — CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 (April 28, 2003)

Other clearances for product code GGC

  • K102552 — HEMOSIL LA POSITIVE CONTROL (April 5, 2011)
  • K100103 — SPECIALTY ASSAYED CONTROL-2 (December 15, 2010)
  • K062306 — PLASMACON N, PLASMACON L-1, PLASMACON L-2 (March 16, 2007)
  • K061803 — STA - CONTROL LA 1+2 (July 28, 2006)
  • K023312 — CONTROL PLASMA P (November 1, 2002)
  • K020878 — LYPHOCHEK HEMOSTASIS, MODELS 798, 799 (April 15, 2002)
  • K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (February 6, 2002)
  • K012422 — K-ASSAY D-DIMER CONTROLS (August 21, 2001)
  • K003329 — SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 (March 1, 2001)
  • K993332 — GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 (February 16, 2000)

FDA data resources