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510(k) K951943

CHROM Z CHROMOGENIC ASSAYS by Helena Laboratories — Product Code JBQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1995
Date Received
April 26, 1995
Clearance Type
Traditional
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)
  • K062431 — HEMOSIL LIQUID ANTITHROMBIN (September 1, 2006)
  • 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)