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510(k) K980499

IL TEST ANTITHROMBIN by Instrumentation Laboratory CO — Product Code JBQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1998
Date Received
February 9, 1998
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

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  • K023991 — CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 (April 28, 2003)
  • K022550 — COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS (August 27, 2002)
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