FDA Product Code
FDA Product Code CGA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1345
510(k) Clearances — 401 records · page 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K861653 | GLUCOSE HK PROCEDURE | Data Medical Associates, Inc. | 1986-05-23 | Traditional | PDF ↗ |
| K861204 | GLUCOSE OXIDASE PROCEDURE | Data Medical Associates, Inc. | 1986-04-24 | Traditional | PDF ↗ |
| K855194 | GLUCOSE OXIDASE REAGENT SET | Technostics Intl. | 1986-01-14 | Traditional | PDF ↗ |
| K854177 | IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE | Clinical Data, Inc. | 1985-11-25 | Traditional | PDF ↗ |
| K854335 | GLUCOSE REAGENT SET (GOD/TRINDER) | Sterling Diagnostics, Inc. | 1985-11-22 | Traditional | PDF ↗ |
| K854260 | CHEMPRO 1000 | Sen Tech Medical Corp. | 1985-11-19 | Traditional | PDF ↗ |
| K851822 | BETA SCAN TRENDS METER | Orange Medical Instruments, Inc. | 1985-10-03 | Traditional | PDF ↗ |
| K853656 | QCA ENZYMATIC GLUCOSE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-09-16 | Traditional | PDF ↗ |
| K851703 | GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT | Miles Laboratories, Inc. | 1985-08-23 | Traditional | PDF ↗ |
| K851618 | DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS | Home Diagnostics, Inc. | 1985-08-06 | Traditional | PDF ↗ |
| K851456 | ACCU-CHEK II | Boehringer Mannheim Corp. | 1985-08-01 | Traditional | PDF ↗ |
| K852130 | GLUCOSE(TRINDER) REAGENT | Sigma Diagnostics, Inc. | 1985-06-10 | Traditional | PDF ↗ |
| K851992 | GLU(GOD) REAGENT | Alpkem Corp. | 1985-05-29 | Traditional | PDF ↗ |
| K850257 | BCS GLUCOSE COLORIMETRIC TEST | Bioclinical Systems, Inc. | 1985-03-05 | Traditional | PDF ↗ |
| K850364 | GLUCOSE - TRINDER- REAGENT | Sigma Chemical Co. | 1985-03-05 | Traditional | PDF ↗ |
| K843528 | GLUCOSE OXIDASE ENZYMATIC REAGENT SET | Livonia Diagnostics, Inc. | 1984-09-28 | Traditional | PDF ↗ |
| K843003 | GLUCOSE AUTO& STAT GA-1120 | Kyoto Diagnostics, Inc. | 1984-09-28 | Traditional | PDF ↗ |
| K842684 | DIATROL BLOOD GLUCOSE TEST SYS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-09-07 | Traditional | PDF ↗ |
| K843151 | SYSTEMATE GLUCOSE 67215 | Em Diagnostic Systems, Inc. | 1984-08-27 | Traditional | PDF ↗ |
| K841369 | BETA SCAN DRYSTIX | Orange Medical Instruments, Inc. | 1984-08-23 | Traditional | PDF ↗ |
| K842393 | BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE | Boehringer Mannheim Corp. | 1984-08-16 | Traditional | PDF ↗ |
| K842506 | GLUCOSE-TRINDER-ADDAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-07-19 | Traditional | PDF ↗ |
| K842221 | WAKO GLUCOSE C | Wako Pure Chemical Industries, Ltd. | 1984-07-12 | Traditional | PDF ↗ |
| K842207 | WAKO B.G. PRETEST STRIPS | Healthdyne, Inc. | 1984-06-26 | Traditional | PDF ↗ |
| K840962 | REFLOCHECK-S | Boehringer Mannheim Corp. | 1984-06-22 | Traditional | PDF ↗ |
| K840484 | DIATRON EASYTEST BLOOD GLUCOSE MONI | Medivix, Inc. | 1984-06-22 | Traditional | PDF ↗ |
| K841055 | GLUCOSE ENZYMATIC REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K834271 | REFLOCHECK & GLUCOSE TEST STRIP SYS | Boehringer Mannheim Corp. | 1984-02-13 | Traditional | PDF ↗ |
| K833257 | WAKO GLUCOSE C | Wako Chemicals USA, Inc. | 1983-12-08 | Traditional | PDF ↗ |
| K832691 | BETA SCAN REAGENT STRIP | Orange Medical Instruments, Inc. | 1983-11-14 | Traditional | PDF ↗ |
| K833069 | TDX GLUCOSE | Abbott Laboratories | 1983-11-07 | Traditional | PDF ↗ |
| K831194 | GLUCOKEY | Ulster Scientific, Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K832926 | ENZYMATIC GLUCOSE DETERMINATION | Seragen Diagnostics, Inc. | 1983-10-28 | Traditional | PDF ↗ |
| K832159 | UNITIZED ENZYMATIC GLUCOSE TEST SET | Stanbio Laboratory | 1983-08-16 | Traditional | PDF ↗ |
| K831989 | VISIDEX II REAGENT STRIPS | Miles Laboratories, Inc. | 1983-08-08 | Traditional | PDF ↗ |
| K831634 | GLUCOSE REAGENT B6360-11 | American Scientific Products | 1983-07-19 | Traditional | PDF ↗ |
| K831624 | GLUCOSE REAGENT KITS-B6370-10A | American Scientific Products | 1983-07-06 | Traditional | PDF ↗ |
| K831411 | GLUCOSE OXIDASE/PEROXIDASE TEST | King Diagnostics, Inc. | 1983-07-06 | Traditional | PDF ↗ |
| K823474 | ENZYMATIC GLUCOSE DETERMINATION | The Dow Chemical Co. | 1982-12-30 | Traditional | PDF ↗ |
| K822976 | HYPOCOUNT A | Pharmaquest Corp. | 1982-11-16 | Traditional | PDF ↗ |
| K822486 | HOME BLOOD GLUCOSE MONITOR | Pharmaquest Corp. | 1982-11-05 | Traditional | PDF ↗ |
| K822699 | GLUCOSCAN METER MODEL II | Lifescan, Inc. | 1982-11-05 | Traditional | PDF ↗ |
| K822958 | LANCER MSH GLUCOSE DIAG. KIT | Sherwood Medical Co. | 1982-11-05 | Traditional | PDF ↗ |
| K822697 | GLUCOSCAN TEST STRIPS | Lifescan, Inc. | 1982-09-30 | Traditional | PDF ↗ |
| K821204 | GLUCOSE(ENZYMATIC) REAGENT SET | Omega Medical Electronics | 1982-07-22 | Traditional | PDF ↗ |
| K821192 | YSI #24 & 24M GLUCOSE ANALYZERS | Yellow Springs Instrument Co., Inc. | 1982-06-14 | Traditional | PDF ↗ |
| K821247 | ACCUDEX REAGENT STRIPS | Miles Laboratories, Inc. | 1982-05-21 | Traditional | PDF ↗ |
| K821179 | VISIDEX REAGENT STRIPS | Miles Laboratories, Inc. | 1982-05-14 | Traditional | PDF ↗ |
| K821091 | ACCUCHEK BG. | Biodynamics Corp. | 1982-05-14 | Traditional | PDF ↗ |
| K820465 | CHEMSTRIP UG | Biodynamics Corp. | 1982-03-11 | Traditional | PDF ↗ |
| K813555 | GLUCOSE ENZYME-COLOR REAGENT SET | Biorent Diagnostic, Inc. | 1982-01-18 | Traditional | PDF ↗ |
| K813412 | GLUCOSE ENZYME-COLOR REAGENT SET | Diagnostic Specialties | 1981-12-31 | Traditional | PDF ↗ |
| K813370 | ELECTROLYTE GEL | Hi Chem, Inc. | 1981-12-22 | Traditional | PDF ↗ |
| K812866 | ASTRA REAGENT CONCENTRATE SYSTEM | Nobel Scientific Industries, Inc. | 1981-12-17 | Traditional | PDF ↗ |
| K813168 | LIQUIZYME GLUCOSE REAGENT | American Research Products Co. | 1981-12-03 | Traditional | PDF ↗ |
| K812258 | ACR ENZYMATIC GLUCOSE OXIDASE | Harleco | 1981-08-31 | Traditional | PDF ↗ |
| K811165 | GLUCOSE OXIDASE RATE REAGENT | Chem-Elec, Inc. | 1981-08-13 | Traditional | PDF ↗ |
| K811882 | KING DIAGNOSTICS GLUCOSE TEST | King Diagnostics, Inc. | 1981-07-23 | Traditional | PDF ↗ |
| K811592 | LIQUIZYME SINGLE SOLUTION GLUCOSE REAG | Amresco, Inc. | 1981-07-01 | Traditional | PDF ↗ |
| K811392 | AMES SERA-PAK GLUCOSE REAGENT | Miles Laboratories, Inc. | 1981-05-29 | Traditional | PDF ↗ |
| K810993 | GLUCOSCAN TEST STRIPS | Lifescan, Inc. | 1981-04-29 | Traditional | PDF ↗ |
| K811074 | GLUCOSE REAGENT-ENZYMATIC-COLOR 500 | Reagents Applications, Inc. | 1981-04-29 | Traditional | PDF ↗ |
| K810639 | SERALYZER SYSTEM | Miles Laboratories, Inc. | 1981-03-31 | Traditional | PDF ↗ |
| K810674 | GLUCOSE OXIDASE | Pointe Scientific, Inc., | 1981-03-31 | Traditional | PDF ↗ |
| K810567 | GERMCO TEST R GLUCOSE TEST KIT | Fermco Biochemics, Inc. | 1981-03-13 | Traditional | PDF ↗ |
| K801897 | GLUCOSE DIAGNOSTIC REAGENT | Connecticut Diagnostics, Ltd. | 1980-10-10 | Traditional | PDF ↗ |
| K801600 | GLUCOSE (TRINDER) REAGENT | Gilford Diagnostics | 1980-08-27 | Traditional | PDF ↗ |
| K801663 | SERALYZER GLUCOSE REAGENT STRIPS | Miles Laboratories, Inc. | 1980-08-20 | Traditional | PDF ↗ |
| K800687 | REAGENT FOR DETERM. GLUCOSE IN H/SERUM | Diagnostic Solutions, Inc. | 1980-05-28 | Traditional | PDF ↗ |
| K801071 | LANCER GLUCOSE RATE REAGENT KIT | Sherwood Medical Industries | 1980-05-23 | Traditional | PDF ↗ |
| K800589 | GLUCOSE OXIDASE REAGENT | Nobel Scientific Industries, Inc. | 1980-04-04 | Traditional | PDF ↗ |
| K800200 | LINEAR ENZYMATIC GLUCOSE SYSTEM | Simmler, Inc. | 1980-02-21 | Traditional | PDF ↗ |
| K800070 | GLUCOSE OXIDASE REAGENT KIT | Fisher Scientific Co., LLC | 1980-02-05 | Traditional | PDF ↗ |
| K792534 | NEOCHROME II GLUCOSE, #4044 | American Monitor Corp. | 1980-01-16 | Traditional | PDF ↗ |
| K792398 | ELVI GLUCOSE | Volu Sol Medical Industries | 1979-12-07 | Traditional | PDF ↗ |
| K791989 | TECHNICON C202 SYSTEM | Technicon Instruments Corp. | 1979-10-17 | Traditional | PDF ↗ |
| K791869 | GLUCOSE OXIDASE (FRINDER) KIT | Mid Tech, Inc. | 1979-10-01 | Traditional | PDF ↗ |
| K791669 | GLUCOSE OXIDASE REAGENT SET | Macomb Chemical Co. | 1979-09-24 | Traditional | PDF ↗ |
| K791685 | GLUCOSE REAGENT | Hi Chem, Inc. | 1979-09-17 | Traditional | PDF ↗ |
| K791066 | GLUCOSE GOD-PAP TRINDER METHOD TEST KIT | Fermco Biochemics, Inc. | 1979-09-04 | Traditional | PDF ↗ |
| K781945 | GLUCOSE OXIDASE REAGENT | Fermco Biochemics, Inc. | 1979-01-17 | Traditional | PDF ↗ |
| K781342 | GLUCOSE TEST | Wako Intl., Inc. | 1978-08-31 | Traditional | PDF ↗ |
| K781307 | GLUCOSE DETERM. KIT | Analytical & Research Chemicals, Inc. | 1978-08-31 | Traditional | PDF ↗ |
| K781075 | STATTEK-GLUCOSE LOW LEVEL | Boehringer Mannheim Corp. | 1978-08-14 | Traditional | PDF ↗ |
| K780393 | BIOSTATOR GLUCOSE ANALYZER | Miles Laboratories, Inc. | 1978-06-19 | Traditional | PDF ↗ |
| K780512 | AUTO/STAT KIT | Pierce Chemical Co. | 1978-05-03 | Traditional | PDF ↗ |
| K772308 | AUTOZYME GLUCOSE OXIDASE (TRINDER) | J.T. Baker Chemical Co. | 1978-03-03 | Traditional | PDF ↗ |
| K780093 | GLUCOSE REAGENT FOR GLUCOSE ANALYZER | Harleco | 1978-02-13 | Traditional | PDF ↗ |
| K771754 | GLUCOSE REAGENT FOR GLUC. ANALYZER | Harleco | 1977-10-18 | Traditional | PDF ↗ |
| K771471 | MULTISTAT III GLUCOSE TEST | Instrumentation Laboratory CO | 1977-09-12 | Traditional | PDF ↗ |
| K771059 | DIAG. OZYRATE GLUCOSE REAG. SET | J.T. Baker Chemical Co. | 1977-07-21 | Traditional | PDF ↗ |
| K771000 | TRENDAR | Hi Chem, Inc. | 1977-07-15 | Traditional | PDF ↗ |
| K771001 | STATZYME GLUCOSE | Worthington Biochemical Corp. | 1977-07-11 | Traditional | PDF ↗ |
| K770317 | GLUCOSE TRINDER, ENZYMATIC | Icn Pharmaceuticals, Inc. | 1977-03-30 | Traditional | PDF ↗ |
| K770200 | GO/HPO-GLUCOSE REAGENT (TRINDER) | Beckman Instruments, Inc. | 1977-02-23 | Traditional | PDF ↗ |
| K761148 | REFLOMAT/REFLOTEST SYSTEM | Boehringer Mannheim Corp. | 1977-02-11 | Traditional | PDF ↗ |
| K761060 | GLUCOSE ANALYZER 2 | Beckman Instruments, Inc. | 1977-01-25 | Traditional | PDF ↗ |
| K761181 | GLUCOSE OXIDASE REAGENT SYSTEM | Nobel Scientific Industries, Inc. | 1976-12-13 | Traditional | PDF ↗ |
| K761154 | GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ | Advanced Biomedical Methods, Inc. | 1976-12-09 | Traditional | PDF ↗ |
| K761153 | GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE | Advanced Biomedical Methods, Inc. | 1976-12-09 | Traditional | PDF ↗ |
Product code CGA · Class II · Clinical Chemistry. Data: openFDA.