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510(k) K992456

GRADILEIDEN V TEST by Gradipore , Ltd. — Product Code GGW

K992456 is an FDA 510(k) premarket notification submitted by Gradipore , Ltd. for the device "GRADILEIDEN V TEST". The FDA issued a decision of Substantially Equivalent on December 21, 1999. The device falls under product code GGW (Test, Time, Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. Gradipore , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1999
Date Received
July 23, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
Submission Type

Other clearances by Gradipore , Ltd.

  • K993332 — GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 (February 16, 2000)
  • K922156 — LUCOR CONFIRMATORY REAGENT (April 6, 1993)
  • K903037 — LUPO-TEST REAGENT (December 17, 1990)

Other clearances for product code GGW

  • K260551 — HemosIL Factor V Leiden (APC Resistance V) (March 20, 2026)
  • K090105 — LUPOTEK KCT (December 30, 2010)
  • K083729 — HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHE (May 8, 2009)
  • K060284 — CRYOCHECK CLOT APCR (May 10, 2006)
  • K042762 — PEFAKIT APC-R FACTOR V LEIDEN (December 22, 2004)
  • K033471 — PHOSPHOLIN ES AND CALCIUM CHLORIDE (February 4, 2004)
  • K982062 — CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 (January 13, 1999)
  • K963111 — COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S (December 23, 1996)
  • K945940 — COATEST(R) APC(TM) RESISTANCE (August 7, 1995)
  • K941210 — PTT-LT TEST KIT (March 21, 1995)

FDA data resources