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510(k) K993332

GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 by Gradipore , Ltd. — Product Code GGC

K993332 is an FDA 510(k) premarket notification submitted by Gradipore , Ltd. for the device "GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05". The FDA issued a decision of Substantially Equivalent on February 16, 2000. The device falls under product code GGC (Control, Plasma, Abnormal), a Class II device regulated under 21 CFR 864.5425. Gradipore , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2000
Date Received
October 4, 1999
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 Gradipore , Ltd.

  • K992456 — GRADILEIDEN V TEST (December 21, 1999)
  • K922156 — LUCOR CONFIRMATORY REAGENT (April 6, 1993)
  • K903037 — LUPO-TEST REAGENT (December 17, 1990)

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)
  • K032804 — CRYOCHECK WEAK LUPUS POSITIVE CONTROL (November 3, 2003)
  • 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)

FDA data resources