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401 FDA 510(k) clearances · Product code

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RecordFirmDate
GLUCOSE HK PROCEDURE (K861653)Data Medical Associates, Inc.1986-05-23
GLUCOSE OXIDASE PROCEDURE (K861204)Data Medical Associates, Inc.1986-04-24
GLUCOSE OXIDASE REAGENT SET (K855194)Technostics Intl.1986-01-14
IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE (K854177)Clinical Data, Inc.1985-11-25
GLUCOSE REAGENT SET (GOD/TRINDER) (K854335)Sterling Diagnostics, Inc.1985-11-22
CHEMPRO 1000 (K854260)Sen Tech Medical Corp.1985-11-19
BETA SCAN TRENDS METER (K851822)Orange Medical Instruments, Inc.1985-10-03
QCA ENZYMATIC GLUCOSE (K853656)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-09-16
GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT (K851703)Miles Laboratories, Inc.1985-08-23
DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS (K851618)Home Diagnostics, Inc.1985-08-06
ACCU-CHEK II (K851456)Boehringer Mannheim Corp.1985-08-01
GLUCOSE(TRINDER) REAGENT (K852130)Sigma Diagnostics, Inc.1985-06-10
GLU(GOD) REAGENT (K851992)Alpkem Corp.1985-05-29
GLUCOSE - TRINDER- REAGENT (K850364)Sigma Chemical Co.1985-03-05
BCS GLUCOSE COLORIMETRIC TEST (K850257)Bioclinical Systems, Inc.1985-03-05
GLUCOSE AUTO& STAT GA-1120 (K843003)Kyoto Diagnostics, Inc.1984-09-28
GLUCOSE OXIDASE ENZYMATIC REAGENT SET (K843528)Livonia Diagnostics, Inc.1984-09-28
DIATROL BLOOD GLUCOSE TEST SYS (K842684)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-09-07
SYSTEMATE GLUCOSE 67215 (K843151)Em Diagnostic Systems, Inc.1984-08-27
BETA SCAN DRYSTIX (K841369)Orange Medical Instruments, Inc.1984-08-23
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE (K842393)Boehringer Mannheim Corp.1984-08-16
GLUCOSE-TRINDER-ADDAY KIT (K842506)Diagnostic Chemicals, Ltd. (Usa)1984-07-19
WAKO GLUCOSE C (K842221)Wako Pure Chemical Industries, Ltd.1984-07-12
WAKO B.G. PRETEST STRIPS (K842207)Healthdyne, Inc.1984-06-26
REFLOCHECK-S (K840962)Boehringer Mannheim Corp.1984-06-22
DIATRON EASYTEST BLOOD GLUCOSE MONI (K840484)Medivix, Inc.1984-06-22
GLUCOSE ENZYMATIC REAGENT SET (K841055)Medical Specialties, Inc.1984-05-01
REFLOCHECK & GLUCOSE TEST STRIP SYS (K834271)Boehringer Mannheim Corp.1984-02-13
WAKO GLUCOSE C (K833257)Wako Chemicals USA, Inc.1983-12-08
BETA SCAN REAGENT STRIP (K832691)Orange Medical Instruments, Inc.1983-11-14
TDX GLUCOSE (K833069)Abbott Laboratories1983-11-07
GLUCOKEY (K831194)Ulster Scientific, Inc.1983-10-31
ENZYMATIC GLUCOSE DETERMINATION (K832926)Seragen Diagnostics, Inc.1983-10-28
UNITIZED ENZYMATIC GLUCOSE TEST SET (K832159)Stanbio Laboratory1983-08-16
VISIDEX II REAGENT STRIPS (K831989)Miles Laboratories, Inc.1983-08-08
GLUCOSE REAGENT B6360-11 (K831634)American Scientific Products1983-07-19
GLUCOSE OXIDASE/PEROXIDASE TEST (K831411)King Diagnostics, Inc.1983-07-06
GLUCOSE REAGENT KITS-B6370-10A (K831624)American Scientific Products1983-07-06
ENZYMATIC GLUCOSE DETERMINATION (K823474)The Dow Chemical Co.1982-12-30
HYPOCOUNT A (K822976)Pharmaquest Corp.1982-11-16
LANCER MSH GLUCOSE DIAG. KIT (K822958)Sherwood Medical Co.1982-11-05
GLUCOSCAN METER MODEL II (K822699)Lifescan, Inc.1982-11-05
HOME BLOOD GLUCOSE MONITOR (K822486)Pharmaquest Corp.1982-11-05
GLUCOSCAN TEST STRIPS (K822697)Lifescan, Inc.1982-09-30
GLUCOSE(ENZYMATIC) REAGENT SET (K821204)Omega Medical Electronics1982-07-22
YSI #24 & 24M GLUCOSE ANALYZERS (K821192)Yellow Springs Instrument Co., Inc.1982-06-14
ACCUDEX REAGENT STRIPS (K821247)Miles Laboratories, Inc.1982-05-21
VISIDEX REAGENT STRIPS (K821179)Miles Laboratories, Inc.1982-05-14
ACCUCHEK BG. (K821091)Biodynamics Corp.1982-05-14
CHEMSTRIP UG (K820465)Biodynamics Corp.1982-03-11
GLUCOSE ENZYME-COLOR REAGENT SET (K813555)Biorent Diagnostic, Inc.1982-01-18
GLUCOSE ENZYME-COLOR REAGENT SET (K813412)Diagnostic Specialties1981-12-31
ELECTROLYTE GEL (K813370)Hi Chem, Inc.1981-12-22
ASTRA REAGENT CONCENTRATE SYSTEM (K812866)Nobel Scientific Industries, Inc.1981-12-17
LIQUIZYME GLUCOSE REAGENT (K813168)American Research Products Co.1981-12-03
ACR ENZYMATIC GLUCOSE OXIDASE (K812258)Harleco1981-08-31
GLUCOSE OXIDASE RATE REAGENT (K811165)Chem-Elec, Inc.1981-08-13
KING DIAGNOSTICS GLUCOSE TEST (K811882)King Diagnostics, Inc.1981-07-23
LIQUIZYME SINGLE SOLUTION GLUCOSE REAG (K811592)Amresco, Inc.1981-07-01
AMES SERA-PAK GLUCOSE REAGENT (K811392)Miles Laboratories, Inc.1981-05-29
GLUCOSCAN TEST STRIPS (K810993)Lifescan, Inc.1981-04-29
GLUCOSE REAGENT-ENZYMATIC-COLOR 500 (K811074)Reagents Applications, Inc.1981-04-29
SERALYZER SYSTEM (K810639)Miles Laboratories, Inc.1981-03-31
GLUCOSE OXIDASE (K810674)Pointe Scientific, Inc.,1981-03-31
GERMCO TEST R GLUCOSE TEST KIT (K810567)Fermco Biochemics, Inc.1981-03-13
GLUCOSE DIAGNOSTIC REAGENT (K801897)Connecticut Diagnostics, Ltd.1980-10-10
GLUCOSE (TRINDER) REAGENT (K801600)Gilford Diagnostics1980-08-27
SERALYZER GLUCOSE REAGENT STRIPS (K801663)Miles Laboratories, Inc.1980-08-20
REAGENT FOR DETERM. GLUCOSE IN H/SERUM (K800687)Diagnostic Solutions, Inc.1980-05-28
LANCER GLUCOSE RATE REAGENT KIT (K801071)Sherwood Medical Industries1980-05-23
GLUCOSE OXIDASE REAGENT (K800589)Nobel Scientific Industries, Inc.1980-04-04
LINEAR ENZYMATIC GLUCOSE SYSTEM (K800200)Simmler, Inc.1980-02-21
GLUCOSE OXIDASE REAGENT KIT (K800070)Fisher Scientific Co., LLC1980-02-05
NEOCHROME II GLUCOSE, #4044 (K792534)American Monitor Corp.1980-01-16
ELVI GLUCOSE (K792398)Volu Sol Medical Industries1979-12-07
TECHNICON C202 SYSTEM (K791989)Technicon Instruments Corp.1979-10-17
GLUCOSE OXIDASE (FRINDER) KIT (K791869)Mid Tech, Inc.1979-10-01
GLUCOSE OXIDASE REAGENT SET (K791669)Macomb Chemical Co.1979-09-24
GLUCOSE REAGENT (K791685)Hi Chem, Inc.1979-09-17
GLUCOSE GOD-PAP TRINDER METHOD TEST KIT (K791066)Fermco Biochemics, Inc.1979-09-04
GLUCOSE OXIDASE REAGENT (K781945)Fermco Biochemics, Inc.1979-01-17
GLUCOSE TEST (K781342)Wako Intl., Inc.1978-08-31
GLUCOSE DETERM. KIT (K781307)Analytical & Research Chemicals, Inc.1978-08-31
STATTEK-GLUCOSE LOW LEVEL (K781075)Boehringer Mannheim Corp.1978-08-14
BIOSTATOR GLUCOSE ANALYZER (K780393)Miles Laboratories, Inc.1978-06-19
AUTO/STAT KIT (K780512)Pierce Chemical Co.1978-05-03
AUTOZYME GLUCOSE OXIDASE (TRINDER) (K772308)J.T. Baker Chemical Co.1978-03-03
GLUCOSE REAGENT FOR GLUCOSE ANALYZER (K780093)Harleco1978-02-13
GLUCOSE REAGENT FOR GLUC. ANALYZER (K771754)Harleco1977-10-18
MULTISTAT III GLUCOSE TEST (K771471)Instrumentation Laboratory CO1977-09-12
DIAG. OZYRATE GLUCOSE REAG. SET (K771059)J.T. Baker Chemical Co.1977-07-21
TRENDAR (K771000)Hi Chem, Inc.1977-07-15
STATZYME GLUCOSE (K771001)Worthington Biochemical Corp.1977-07-11
GLUCOSE TRINDER, ENZYMATIC (K770317)Icn Pharmaceuticals, Inc.1977-03-30
GO/HPO-GLUCOSE REAGENT (TRINDER) (K770200)Beckman Instruments, Inc.1977-02-23
REFLOMAT/REFLOTEST SYSTEM (K761148)Boehringer Mannheim Corp.1977-02-11
GLUCOSE ANALYZER 2 (K761060)Beckman Instruments, Inc.1977-01-25
GLUCOSE OXIDASE REAGENT SYSTEM (K761181)Nobel Scientific Industries, Inc.1976-12-13
GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ (K761154)Advanced Biomedical Methods, Inc.1976-12-09
GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE (K761153)Advanced Biomedical Methods, Inc.1976-12-09
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