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510(k) K071712

LEUKO EZ VUE by Techlab Inc., Corporate Research Center — Product Code DEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2007
Date Received
June 22, 2007
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

Other clearances by Techlab Inc., Corporate Research Center

  • K121364 — SHIGA TOXIN QUIK CHEK (October 2, 2012)
  • K121411 — SHIGA TOXIN CHEK (October 2, 2012)
  • K103673 — GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK (August 18, 2011)
  • K071711 — ASCA-CHEK (November 7, 2007)

Other clearances for product code DEG

  • K042071 — IBD-SCAN (October 20, 2004)
  • 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)