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401 FDA 510(k) clearances · Product code

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RecordFirmDate
GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION (K934898)Heraeus Kulzer, Inc.1993-12-07
GLUCOSTIX REAGENT STRIPS (K926362)Heraeus Kulzer, Inc.1993-11-10
CHOLESTECH L.D.X. SYSTEM (K932727)Cholestech Corp.1993-11-09
GLUCOFILM TEST STRIPS (K926360)Heraeus Kulzer, Inc.1993-09-08
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM (K930979)Boehringer Mannheim Corp.1993-09-08
ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP (K922136)Home Diagnostics, Inc.1993-08-10
DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP (K922137)Home Diagnostics, Inc.1993-08-10
GLUCOMETER M+ BLOOD GLUCOSE METER (K931310)Heraeus Kulzer, Inc.1993-06-25
TES-TAPE (K922207)Lilly Research Laboratories1993-06-15
CHECKMATE PLUS BLOOD GLUCOSE METER, TEST STRIP,ETC (K931188)Cascade Medical, Inc.1993-05-26
HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 (K925551)Hichem Diagnostics1993-04-20
GLUCOSE TEST SYSTEM (K923587)Polymer Technology Corp.1992-12-28
UNI-CHECK REAGENT STRIP (K924398)Diagnostic Solutions, Inc.1992-12-23
ELITE TEST STRIPS GLUCOMETER (K924499)Heraeus Kulzer, Inc.1992-12-17
ONE TOUCH TEST STRIPS (K923544)Lifescan, Inc.1992-12-03
NOVA 12 ANALYZER, MODIFICATION (K924743)Nova Biomedical Corp.1992-11-06
ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM (K923048)Boehringer Mannheim Corp.1992-10-14
ACCUDATA GLUCOSE TEST STATION (K924475)Boehringer Mannheim Corp.1992-10-13
IL TEST GLUCOSE, PN 181633-80 (K922532)Instrumentation Laboratory CO1992-09-30
GLUCOSE 3 (K922035)Caro Med, Inc.1992-09-23
ONE TOUCH IIB BLOOD GLUCOSE METER (K922888)Lifescan, Inc.1992-09-15
QUICK-CHECK II REAGENT STRIP (K921825)Diagnostic Solutions, Inc.1992-08-18
ULTRA+ BLOOD GLUCOSE TEST STRIP (K915770)Home Diagnostics, Inc.1992-04-14
DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP (K915772)Home Diagnostics, Inc.1992-04-14
FIRST CHOICE (K912580)Polymer Technology Corp.1992-03-04
GLUCOSE REAGENT SET (K914159)Tech Intl. Co.1992-01-27
ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST (K913357)Lifescan, Inc.1991-11-07
YSI MODEL 2300 STAT PLUS (K913806)Ysis, Inc.1991-10-02
FIRST CHOICE(TM) (K912732)Polymer Technology Corp.1991-09-10
ULTRA BLOOD GLUCOSE MONITORING SYSTEM (K912440)Home Diagnostics, Inc.1991-07-17
VISION BG TEST STRIP (K911624)British-American Medical, Inc.1991-07-17
VISION BG MONITOR (K911596)British-American Medical, Inc.1991-05-15
FIRST CHOICE(TM), MODIFICATION (K911792)Polymer Technology Corp.1991-05-15
HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER (K911141)Hemocue, Inc.1991-05-08
YSI MODEL 1500 BLOOD GLUCOSE ANALYZER (K910633)Yellow Springs Instrument Co., Inc.1991-04-12
GLUCOSE V (K910573)Caro Med, Inc.1991-04-03
BIO SCAN-BG(TM (K910692)Bio Scan Instrument, Inc.1991-03-29
CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST (K904082)Cholestech Corp.1990-12-26
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM (K904081)Heraeus Kulzer, Inc.1990-12-26
ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM (K904292)Boehringer Mannheim Corp.1990-10-22
ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM (K904168)Boehringer Mannheim Corp.1990-10-15
QUICK CHECK 3 FILM (K903191)Quantai Biotronics, Inc.1990-10-15
SYNERMED GLUCOSE REAGENT KIT (K903063)Synermed, Inc.1990-09-13
MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM (K901613)Medisense, Inc.1990-07-10
GLUCOMETER GX BLOOD GLUCOSE METER (K897015)Heraeus Kulzer, Inc.1990-03-29
SATELLITE G BLOOD GLUCOSE MONITORING SYSTEM (K896951)Medisense, Inc.1990-02-26
AUTOSCAN, AUTOSTRIP AND AUTOCONTROL (K896144)Cascade Medical, Inc.1989-12-19
QUANTAI UG REAGENT STRIP (K893661)Quantai Biotronics, Inc.1989-11-08
ONE TOUCH II METER (K895911)Lifescan, Inc.1989-11-08
COBAS READY GLUCOSE REAGENT (K895526)Roche Diagnostic Systems, Inc.1989-10-16
FIRST CHOICE (TM) (K893205)Polymer Technology Corp.1989-10-06
INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM (K893404)Apprise, Inc.1989-08-03
STAT CHEM SYSTEM (K891050)Diagnostic Resources, Inc.1989-07-20
GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST (K893117)Bayer Corp.1989-06-16
NEOCHROME(R) III GLUCOSE (K892002)American Monitor Corp.1989-06-12
YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER (K891480)Yellow Springs Instrument Co., Inc.1989-05-22
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3 (K890873)Heraeus Kulzer, Inc.1989-04-04
ROCHE CHLORIDE ELECTRODE (K890528)Roche Diagnostic Systems, Inc.1989-03-31
APEC GLUCOSE ANALYZER (K890524)Amdev, Inc.1989-03-15
GLUCOSE (GOD) REAGENT (K890336)Alpkem Corp.1989-02-27
GLUCOSE-SUPER FAST 4983050 AND 4983500 (K882262)American Research Products Co.1989-02-02
CLINISTAT GLUCOSE REAGENT TEST (K884756)Heraeus Kulzer, Inc.1989-01-13
GLUCOSE LIQUID AMRESCO #4628300 & 4628001L (K884909)American Research Products Co.1989-01-03
VISUAL BLOOD GLUCOSE TEST SYSTEM (K884993)Diagnostic Systems1988-12-29
ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM (K883817)Boehringer Mannheim Corp.1988-12-09
MD STRIPS BG (K875049)Amatech International, Inc.1988-08-23
TRACER(TM) II BLOOD GLUCOSE SYSTEM (K881908)Boehringer Mannheim Corp.1988-07-12
QUANTAI BG(TM) REAGENT STRIP (K880703)Quantai Biotronics, Inc.1988-07-08
GLUCOSE (TRINDER) CAT. # 220-32 (K875211)Diagnostic Chemicals, Ltd. (Usa)1988-04-18
DEXPAD, BLOOD GLUCOSE STRIP (K880585)Mach Diag. C/O Wichita State University1988-04-18
ROMEO(TM) MODEL 1000 (K872889)Diva Medical Systems, Inc.1988-04-13
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT (K871835)Miles Laboratories, Inc.1987-12-22
GLUCOSE REAGENT KIT (K873128)A-Kem, Inc.1987-10-23
DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS (K872505)Home Diagnostics, Inc.1987-10-20
GLUCOCHEK S.C. WITH AUDIO OPTION (K871586)Larken Industries, Inc.1987-09-16
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT (K873117)Biotrol, USA, Inc.1987-08-31
NOVOCHECK/CHECKPOINT/CONTROL SOLUTION (K872049)Garid, Inc.1987-08-13
GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA (K864282)Medical Device Consultants, Inc.1987-05-26
GLUCOSE ENZYME - COLOR REAGENT SET (K871650)Biochemical Trade, Inc.1987-05-12
MODIFICATION OF ACCU-CHEK II (K863481)Boehringer Mannheim Corp.1987-04-07
FAST GLUCOSE (K870631)Sclavo, Inc.1987-03-13
DIMENSION-WBG (K863223)Dimension Diagnostics1987-03-10
GLUCOSE OXIDASE REAGENT (K870616)Intersect Systems, Inc.1987-03-06
MPX SYSTEM, GLUCOSE TEST SYSTEM (K864322)Lifescan, Inc.1987-02-25
SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. (K864530)Miles Laboratories, Inc.1987-02-18
ABBOTT SPECTRUM GLUCOSE REAGENT (K864224)Abbott Laboratories1987-01-05
EXACTECH(TM) (K863468)Travenol Laboratories, S.A.1986-12-08
TRACKER SYSTEM (K860948)Boehringer Mannheim Corp.1986-12-08
MED-PEN/MED-POINT (K853733)Garid, Inc.1986-12-04
GLUCOMETER-E (K863102)J. D. Assoc.1986-11-24
A-GENT(TM) LIQUID GLUCOSE TRINDER (K863948)Abbott Laboratories1986-11-13
GLUCOSE OXIDASE (K863926)Tech-Co, Inc.1986-11-13
UNIDEX GLUCOSE TEST STRIP (K862984)Unidex, Inc.1986-11-05
ENZYMATIC BLOOD GLUCOSE (K862721)U. S. Diagnostics, Inc.1986-09-03
GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET (K860682)Gambro, Inc.1986-08-29
DIATRON BLOOD GLUCOSE METER (K855178)Dextron, Inc.1986-08-04
DIAGEM 300 BG REAGENT STRIPS (K854329)Seton Products, Inc.1986-08-04
GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER (K861303)Miles Laboratories, Inc.1986-07-02
GLUCOMETER M BLOOD GULCOSE METER (K855202)Miles Laboratories, Inc.1986-07-02
DIRECT (K852960)University of Wisconsin1986-06-16
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