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510(k) K945940

COATEST(R) APC(TM) RESISTANCE by Axis-Shield Doc AS — Product Code GGW

K945940 is an FDA 510(k) premarket notification submitted by Axis-Shield Doc AS for the device "COATEST(R) APC(TM) RESISTANCE". The FDA issued a decision of Substantially Equivalent on August 7, 1995. The device falls under product code GGW (Test, Time, Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1995
Date Received
December 5, 1994
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

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  • 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)
  • K992456 — GRADILEIDEN V TEST (December 21, 1999)
  • 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)
  • K941210 — PTT-LT TEST KIT (March 21, 1995)

FDA data resources