Home / 510(k) Clearances / K101831

510(k) K101831

ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 by Bionostics, Inc. — Product Code OSL

K101831 is an FDA 510(k) premarket notification submitted by Bionostics, Inc. for the device "ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800". The FDA issued a decision of Substantially Equivalent on October 1, 2010. The device falls under product code OSL (Control, Fecal Occult Blood), a Class II device regulated under 21 CFR 864.6550. Bionostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2010
Date Received
July 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.

Other clearances by Bionostics, Inc.

  • K131136 — GLUCOSE METER-CHECK SOLUTION FOR TAIDOC (May 31, 2013)
  • K123851 — GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK (February 14, 2013)
  • K123966 — GLUCOSE METER-CHECK SOLUTION FOR BAYER (January 25, 2013)
  • K113764 — GLUCOSE METER-CHECK SOLUTION FOR INFOPIA (January 30, 2012)
  • K112352 — GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT (December 23, 2011)
  • K112356 — GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE (September 19, 2011)
  • K103553 — LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION (February 10, 2011)
  • K091914 — OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION (November 6, 2009)
  • K081478 — RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS (October 6, 2008)
  • K082395 — GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MOD (September 18, 2008)

FDA data resources