Product code LFR— Clinical Chemistry
ACCU-CHEK COMFORT CURVE TEST STRIP
- Classification name
- Glucose Dehydrogenase, Glucose
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Total cleared
- 73
- First cleared
- Most recent
Market context for product code LFR
FDA has cleared devices under product code LFR between 1977 and 2015, filed by 27 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2015
- 2014
- 2013
- 2012
- 2011
- 2009
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
- 1999
Top applicants under product code LFR
Adverse events under product code LFR
product code LFR- Death
- 3
- Malfunction
- 1,634
- Total
- 1,637
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code LFR
- K152328 — FreeStyle InsuLinx Blood Glucose Monotioring System
- K142089 — ACCU-CHEK AVIVA EXPERT SYSTEM
- K133537 — EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
- K131727 — CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
- K131366 — ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
- K122688 — NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
- K121433 — GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
- K122435 — NOVA ONE BLOOD GLUCOSE MONITOR
- K113314 — PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
- K121224 — GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
- K113307 — GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM
- K121190 — CONTOUR NEXT BLOOD GLUCOSE METER
- K120042 — TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM
- K121207 — EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
- K113768 — U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM
- K110587 — CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
- K110894 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
- K113243 — EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
- K111268 — CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
- K111874 — FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
- K112901 — EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
- K101299 — ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K110637 — ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM
- K112272 — EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
- K092688 — FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM
- K101037 — EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
- K083223 — RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01
- K070984 — THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
- K060765 — HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712
- K051592 — MODIFICATION TO ACCU-CHEK GO SYSTEM
- K050872 — ACCU-CHEK INTEGRA SYSTEM
- K043474 — ACCU-CHEK AVIVA SYSTEM
- K041230 — CLINICAL LABORATORY ANALYZING SYSTEM
- K040796 — ACCU-CHEK GO SYSTEM
- K032076 — SENOVA(R) BLOOD GLUCOSE MONITOR
- K031755 — ACCU-CHEK COMPACT TEST STRIP
- K022941 — MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING
- K021960 — PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
- K004010 — ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS
- K003846 — ACCU-CHEK INFORM METER
- K010362 — ACCU-CHEK COMFORT CURVE TEST STRIP
- K000582 — FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
- K001993 — SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS
- K994433 — CONNECT DATA MANAGEMENT SYSTEM
- K000364 — ACCU-CHEK COMPLETE METER
- K992684 — FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
- K993829 — ACCU-CHEK SIMPLICITY SYSTEM
- K983047 — ACCU-CHEK HQ SYSTEM
- K982089 — ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS
- K982002 — ACCU-CHEK COMFORT CURVE TEST STRIP
- K982079 — ACCU-CHECK VOICEMATE
- K980731 — ACCU-CHEK COMFORT CURVE TEST STRIPS
- K973662 — ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS
- K972876 — GLUCOTREND BASIC SYSTEM
- K962415 — HEMOCUE B-GLCOSE SYSTEM
- K961311 — HEMOCUE B-GLUCOSE SYSTEM
- K954833 — ACCU-CHEK ADVANTAGE TEST STRIPS
- K951750 — GLUCOSE TEST ITEM NUMBER 97375/94
- K951887 — ADVANTAGE TEST STRIPS
- K870708 — GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM
- K874708 — EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008
- K860726 — ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID
- K855080 — EMDS GLUCOSE TEST PACK ITEM 67656/95
- K821867 — ULTRACHEM GLUC-DH
- K821463 — ULTRACHEM GLUC-DH, #65048
- K821469 — ULTRACHEM GLUC-DH, #65048
- K813427 — ULTRACHEM GLUC-DH
- K813042 — ULTRACHEM GLUC-DH SET, ITEM #65048
- K811202 — ULTRACHEM GLUC-DH, ITEM NO. 65048
- K791213 — GLUCOSE (GDH) REAGENT
- K791110 — KINETIC DETERMINATION OF UV GLUCOSE
- K781783 — BLOOD SUGAR
- K771102 — UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.