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510(k) K062431

HEMOSIL LIQUID ANTITHROMBIN by Instrumentation Laboratory CO — Product Code JBQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2006
Date Received
August 21, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antithrombin Iii Quantitation
Device Class
Class II
Regulation Number
864.7060
Review Panel
HE
Submission Type

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Other clearances for product code JBQ

  • K242952 — INNOVANCE Antithrombin (March 28, 2025)
  • K081769 — INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 (May 28, 2009)
  • K070301 — HEMOSIL ANTITHROMBIN (February 23, 2007)
  • K043007 — BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE (November 7, 2005)
  • K033775 — HEMOSIL LIQUID ANTITHROMBIN XL (January 2, 2004)
  • K023991 — CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 (April 28, 2003)
  • K022550 — COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS (August 27, 2002)
  • K022195 — COAMATIC AT-400 (August 7, 2002)
  • K994238 — IL TEST LIQUID ANTITHROMBIN (June 23, 2000)
  • K000361 — K-ASSAY AT-III (April 26, 2000)