Home / 510(k) Clearances / K951101

510(k) K951101

LEUKO-TEST by Techlab, Inc. — Product Code DEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1995
Date Received
March 10, 1995
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.

  • K191442 — Campylobacter Chek (June 20, 2019)
  • K191456 — Campylobacter Quik Chek (June 20, 2019)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K173219 — CAMPYLOBACTER CHEK (January 22, 2018)
  • K173217 — CAMPYLOBACTER QUIK 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)
  • K042071 — IBD-SCAN (October 20, 2004)
  • K030704 — IBD-QUIK CHEK (April 21, 2003)
  • K011396 — IBD-CHEK (June 18, 2001)
  • K934473 — LACTOFERRIN MICROASSAY SYSTEM (December 3, 1993)
  • K931901 — LACTOCARD (July 6, 1993)
  • K852737 — LACTOPLATE (October 25, 1985)