Home / 510(k) Clearances / K011396

510(k) K011396

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

K011396 is an FDA 510(k) premarket notification submitted by Techlab, Inc. for the device "IBD-CHEK". The FDA issued a decision of Substantially Equivalent on June 18, 2001. The device falls under product code DEG (Lactoferrin, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5570. Techlab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2001
Date Received
May 7, 2001
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)
  • 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)
  • K042071 — IBD-SCAN (October 20, 2004)
  • K030704 — IBD-QUIK CHEK (April 21, 2003)
  • K951101 — LEUKO-TEST (April 24, 1995)
  • K934473 — LACTOFERRIN MICROASSAY SYSTEM (December 3, 1993)
  • K931901 — LACTOCARD (July 6, 1993)
  • K852737 — LACTOPLATE (October 25, 1985)

FDA data resources