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510(k) K042071

IBD-SCAN by Techlab, Inc. — Product Code DEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2004
Date Received
August 2, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lactoferrin, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5570
Review Panel
IM
Submission Type

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  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K173217 — CAMPYLOBACTER QUIK CHEK (January 22, 2018)
  • K173219 — CAMPYLOBACTER CHEK (January 22, 2018)
  • K171078 — TRI-COMBO PARASITE SCREEN (July 10, 2017)
  • K170728 — E. HISTOLYTICA QUIK CHEK (June 7, 2017)
  • K082499 — C. DIFF QUIK CHEK COMPLETE (March 26, 2009)
  • K053572 — C. DIFF QUIK CHEK (April 26, 2006)

Other clearances for product code DEG

  • K071712 — LEUKO EZ VUE (December 4, 2007)
  • K030704 — IBD-QUIK CHEK (April 21, 2003)
  • K011396 — IBD-CHEK (June 18, 2001)
  • K951101 — LEUKO-TEST (April 24, 1995)
  • K934473 — LACTOFERRIN MICROASSAY SYSTEM (December 3, 1993)
  • K931901 — LACTOCARD (July 6, 1993)
  • K852737 — LACTOPLATE (October 25, 1985)