Home / 510(k) Clearances / K896474

510(k) K896474

RESUBMITTED FECATWIN SENSITIVE - FECA-EIA by Labsystems, Inc. — Product Code KHE

K896474 is an FDA 510(k) premarket notification submitted by Labsystems, Inc. for the device "RESUBMITTED FECATWIN SENSITIVE - FECA-EIA". The FDA issued a decision of Substantially Equivalent on January 25, 1990. The device falls under product code KHE (Reagent, Occult Blood), a Class II device regulated under 21 CFR 864.6550. Labsystems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1990
Date Received
November 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Occult Blood
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
Submission Type

Other clearances by Labsystems, Inc.

  • K923365 — TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEM (March 24, 1993)
  • K890154 — MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA (February 7, 1989)
  • K890091 — MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT (February 3, 1989)
  • K881243 — RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201 (April 4, 1988)
  • K873780 — MODIFICATION RUBELLA IGM EIA TEST KIT (October 15, 1987)
  • K873583 — AUTO-EIA (September 22, 1987)
  • K872252 — MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT (July 1, 1987)
  • K862705 — CYTOMEGALOVIRUS IGG EIA TEST KIT (October 1, 1986)
  • K862431 — RUBELLA IGM EIA TEST KIT (August 8, 1986)
  • K862216 — TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) (June 30, 1986)

Other clearances for product code KHE

  • K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood Test (February 15, 2018)
  • K170548 — InSure ONE (October 5, 2017)
  • K171484 — hema-screen SPECIFIC Gold (June 14, 2017)
  • K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test (May 14, 2017)
  • K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (January 17, 2017)
  • K143325 — OC-Light S FIT (August 20, 2015)
  • K121397 — OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 (December 28, 2012)
  • K113506 — IND ONE STEP OCCULT BLOOD (FOB) TEST (December 19, 2012)
  • K110309 — FOB ONE STEP RAPID TEST (September 14, 2011)
  • K102664 — HEMA SCREEN ER (January 28, 2011)

FDA data resources