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510(k) K113314

PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM by Hmd Biomedical, Inc. — Product Code LFR

K113314 is an FDA 510(k) premarket notification submitted by Hmd Biomedical, Inc. for the device "PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 9, 2012. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. Hmd Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2012
Date Received
November 9, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Dehydrogenase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Hmd Biomedical, Inc.

  • K212248 — GlucoLeader Enhance 2 Blood Glucose Monitoring System (August 29, 2022)
  • K182428 — GlucoLeader Enhance Blood Glucose Monitoring System (May 8, 2019)
  • K140150 — Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose M (May 14, 2015)
  • K131173 — FIA Blood Glucose Monitoring System (G2) (September 18, 2014)
  • K121433 — GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) (February 14, 2013)
  • K120064 — TEST, BLOOD GLUCOSE SYSTEM (September 5, 2012)
  • K113307 — GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM (July 27, 2012)
  • K072369 — EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM (March 21, 2008)
  • K032985 — GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM (October 21, 2003)
  • K023279 — GLUCOLEADER VALUE (August 4, 2003)

Other clearances for product code LFR

  • K152328 — FreeStyle InsuLinx Blood Glucose Monotioring System (September 17, 2015)
  • K142089 — ACCU-CHEK AVIVA EXPERT SYSTEM (December 17, 2014)
  • K133537 — EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUC (April 28, 2014)
  • K131727 — CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM (February 28, 2014)
  • K131366 — ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM (October 11, 2013)
  • K122688 — NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR (April 4, 2013)
  • K121433 — GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) (February 14, 2013)
  • K122435 — NOVA ONE BLOOD GLUCOSE MONITOR (December 20, 2012)
  • K121224 — GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM (September 19, 2012)
  • K113307 — GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM (July 27, 2012)

FDA data resources