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 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K931196 | APEC GLUCOSE ANALYZER | Apec, Inc. | 1993-12-07 | Traditional | PDF ↗ |
| K926362 | GLUCOSTIX REAGENT STRIPS | Heraeus Kulzer, Inc. | 1993-11-10 | Traditional | PDF ↗ |
| K932727 | CHOLESTECH L.D.X. SYSTEM | Cholestech Corp. | 1993-11-09 | Traditional | PDF ↗ |
| K926360 | GLUCOFILM TEST STRIPS | Heraeus Kulzer, Inc. | 1993-09-08 | Traditional | PDF ↗ |
| K930979 | ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM | Boehringer Mannheim Corp. | 1993-09-08 | Traditional | PDF ↗ |
| K922137 | DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP | Home Diagnostics, Inc. | 1993-08-10 | Traditional | PDF ↗ |
| K922136 | ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP | Home Diagnostics, Inc. | 1993-08-10 | Traditional | PDF ↗ |
| K931310 | GLUCOMETER M+ BLOOD GLUCOSE METER | Heraeus Kulzer, Inc. | 1993-06-25 | Traditional | PDF ↗ |
| K922207 | TES-TAPE | Lilly Research Laboratories | 1993-06-15 | Traditional | PDF ↗ |
| K931188 | CHECKMATE PLUS BLOOD GLUCOSE METER, TEST STRIP,ETC | Cascade Medical, Inc. | 1993-05-26 | Traditional | PDF ↗ |
| K925551 | HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 | Hichem Diagnostics | 1993-04-20 | Traditional | PDF ↗ |
| K923587 | GLUCOSE TEST SYSTEM | Polymer Technology Corp. | 1992-12-28 | Traditional | PDF ↗ |
| K924398 | UNI-CHECK REAGENT STRIP | Diagnostic Solutions, Inc. | 1992-12-23 | Traditional | PDF ↗ |
| K924499 | ELITE TEST STRIPS GLUCOMETER | Heraeus Kulzer, Inc. | 1992-12-17 | Traditional | PDF ↗ |
| K923544 | ONE TOUCH TEST STRIPS | Lifescan, Inc. | 1992-12-03 | Traditional | PDF ↗ |
| K924743 | NOVA 12 ANALYZER, MODIFICATION | Nova Biomedical Corp. | 1992-11-06 | Traditional | PDF ↗ |
| K923048 | ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM | Boehringer Mannheim Corp. | 1992-10-14 | Traditional | PDF ↗ |
| K924475 | ACCUDATA GLUCOSE TEST STATION | Boehringer Mannheim Corp. | 1992-10-13 | Traditional | PDF ↗ |
| K922532 | IL TEST GLUCOSE, PN 181633-80 | Instrumentation Laboratory CO | 1992-09-30 | Traditional | PDF ↗ |
| K922035 | GLUCOSE 3 | Caro Med, Inc. | 1992-09-23 | Traditional | PDF ↗ |
| K922888 | ONE TOUCH IIB BLOOD GLUCOSE METER | Lifescan, Inc. | 1992-09-15 | Traditional | PDF ↗ |
| K921825 | QUICK-CHECK II REAGENT STRIP | Diagnostic Solutions, Inc. | 1992-08-18 | Traditional | PDF ↗ |
| K915772 | DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP | Home Diagnostics, Inc. | 1992-04-14 | Traditional | PDF ↗ |
| K915770 | ULTRA+ BLOOD GLUCOSE TEST STRIP | Home Diagnostics, Inc. | 1992-04-14 | Traditional | PDF ↗ |
| K912580 | FIRST CHOICE | Polymer Technology Corp. | 1992-03-04 | Traditional | PDF ↗ |
| K914159 | GLUCOSE REAGENT SET | Tech Intl. Co. | 1992-01-27 | Traditional | PDF ↗ |
| K913357 | ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST | Lifescan, Inc. | 1991-11-07 | Traditional | PDF ↗ |
| K913806 | YSI MODEL 2300 STAT PLUS | Ysis, Inc. | 1991-10-02 | Traditional | PDF ↗ |
| K912732 | FIRST CHOICE(TM) | Polymer Technology Corp. | 1991-09-10 | Traditional | PDF ↗ |
| K911624 | VISION BG TEST STRIP | British-American Medical, Inc. | 1991-07-17 | Traditional | PDF ↗ |
| K912440 | ULTRA BLOOD GLUCOSE MONITORING SYSTEM | Home Diagnostics, Inc. | 1991-07-17 | Traditional | PDF ↗ |
| K911596 | VISION BG MONITOR | British-American Medical, Inc. | 1991-05-15 | Traditional | PDF ↗ |
| K911792 | FIRST CHOICE(TM), MODIFICATION | Polymer Technology Corp. | 1991-05-15 | Traditional | PDF ↗ |
| K911141 | HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER | Hemocue, Inc. | 1991-05-08 | Traditional | PDF ↗ |
| K910633 | YSI MODEL 1500 BLOOD GLUCOSE ANALYZER | Yellow Springs Instrument Co., Inc. | 1991-04-12 | Traditional | PDF ↗ |
| K910573 | GLUCOSE V | Caro Med, Inc. | 1991-04-03 | Traditional | PDF ↗ |
| K910692 | BIO SCAN-BG(TM | Bio Scan Instrument, Inc. | 1991-03-29 | Traditional | PDF ↗ |
| K904082 | CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST | Cholestech Corp. | 1990-12-26 | Traditional | PDF ↗ |
| K904081 | GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM | Heraeus Kulzer, Inc. | 1990-12-26 | Traditional | PDF ↗ |
| K904292 | ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM | Boehringer Mannheim Corp. | 1990-10-22 | Traditional | PDF ↗ |
| K904168 | ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM | Boehringer Mannheim Corp. | 1990-10-15 | Traditional | PDF ↗ |
| K903191 | QUICK CHECK 3 FILM | Quantai Biotronics, Inc. | 1990-10-15 | Traditional | PDF ↗ |
| K903063 | SYNERMED GLUCOSE REAGENT KIT | Synermed, Inc. | 1990-09-13 | Traditional | PDF ↗ |
| K901613 | MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM | Medisense, Inc. | 1990-07-10 | Traditional | PDF ↗ |
| K897015 | GLUCOMETER GX BLOOD GLUCOSE METER | Heraeus Kulzer, Inc. | 1990-03-29 | Traditional | PDF ↗ |
| K896951 | SATELLITE G BLOOD GLUCOSE MONITORING SYSTEM | Medisense, Inc. | 1990-02-26 | Traditional | PDF ↗ |
| K896144 | AUTOSCAN, AUTOSTRIP AND AUTOCONTROL | Cascade Medical, Inc. | 1989-12-19 | Traditional | PDF ↗ |
| K895911 | ONE TOUCH II METER | Lifescan, Inc. | 1989-11-08 | Traditional | PDF ↗ |
| K893661 | QUANTAI UG REAGENT STRIP | Quantai Biotronics, Inc. | 1989-11-08 | Traditional | PDF ↗ |
| K895526 | COBAS READY GLUCOSE REAGENT | Roche Diagnostic Systems, Inc. | 1989-10-16 | Traditional | PDF ↗ |
| K893205 | FIRST CHOICE (TM) | Polymer Technology Corp. | 1989-10-06 | Traditional | PDF ↗ |
| K893404 | INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM | Apprise, Inc. | 1989-08-03 | Traditional | PDF ↗ |
| K891050 | STAT CHEM SYSTEM | Diagnostic Resources, Inc. | 1989-07-20 | Traditional | PDF ↗ |
| K893117 | GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST | Bayer Corp. | 1989-06-16 | Traditional | PDF ↗ |
| K892002 | NEOCHROME(R) III GLUCOSE | American Monitor Corp. | 1989-06-12 | Traditional | PDF ↗ |
| K891480 | YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER | Yellow Springs Instrument Co., Inc. | 1989-05-22 | Traditional | PDF ↗ |
| K890873 | GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3 | Heraeus Kulzer, Inc. | 1989-04-04 | Traditional | PDF ↗ |
| K890528 | ROCHE CHLORIDE ELECTRODE | Roche Diagnostic Systems, Inc. | 1989-03-31 | Traditional | PDF ↗ |
| K890524 | APEC GLUCOSE ANALYZER | Amdev, Inc. | 1989-03-15 | Traditional | PDF ↗ |
| K890336 | GLUCOSE (GOD) REAGENT | Alpkem Corp. | 1989-02-27 | Traditional | PDF ↗ |
| K882262 | GLUCOSE-SUPER FAST 4983050 AND 4983500 | American Research Products Co. | 1989-02-02 | Traditional | PDF ↗ |
| K884756 | CLINISTAT GLUCOSE REAGENT TEST | Heraeus Kulzer, Inc. | 1989-01-13 | Traditional | PDF ↗ |
| K884909 | GLUCOSE LIQUID AMRESCO #4628300 & 4628001L | American Research Products Co. | 1989-01-03 | Traditional | PDF ↗ |
| K884993 | VISUAL BLOOD GLUCOSE TEST SYSTEM | Diagnostic Systems | 1988-12-29 | Traditional | PDF ↗ |
| K883817 | ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM | Boehringer Mannheim Corp. | 1988-12-09 | Traditional | PDF ↗ |
| K875049 | MD STRIPS BG | Amatech International, Inc. | 1988-08-23 | Traditional | PDF ↗ |
| K881908 | TRACER(TM) II BLOOD GLUCOSE SYSTEM | Boehringer Mannheim Corp. | 1988-07-12 | Traditional | PDF ↗ |
| K880703 | QUANTAI BG(TM) REAGENT STRIP | Quantai Biotronics, Inc. | 1988-07-08 | Traditional | PDF ↗ |
| K880585 | DEXPAD, BLOOD GLUCOSE STRIP | Mach Diag. C/O Wichita State University | 1988-04-18 | Traditional | PDF ↗ |
| K875211 | GLUCOSE (TRINDER) CAT. # 220-32 | Diagnostic Chemicals, Ltd. (Usa) | 1988-04-18 | Traditional | PDF ↗ |
| K872889 | ROMEO(TM) MODEL 1000 | Diva Medical Systems, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K871835 | GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT | Miles Laboratories, Inc. | 1987-12-22 | Traditional | PDF ↗ |
| K873128 | GLUCOSE REAGENT KIT | A-Kem, Inc. | 1987-10-23 | Traditional | PDF ↗ |
| K872505 | DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS | Home Diagnostics, Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K871586 | GLUCOCHEK S.C. WITH AUDIO OPTION | Larken Industries, Inc. | 1987-09-16 | Traditional | PDF ↗ |
| K873117 | BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT | Biotrol, USA, Inc. | 1987-08-31 | Traditional | PDF ↗ |
| K872049 | NOVOCHECK/CHECKPOINT/CONTROL SOLUTION | Garid, Inc. | 1987-08-13 | Traditional | PDF ↗ |
| K864282 | GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA | Medical Device Consultants, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K871650 | GLUCOSE ENZYME - COLOR REAGENT SET | Biochemical Trade, Inc. | 1987-05-12 | Traditional | PDF ↗ |
| K863481 | MODIFICATION OF ACCU-CHEK II | Boehringer Mannheim Corp. | 1987-04-07 | Traditional | PDF ↗ |
| K870631 | FAST GLUCOSE | Sclavo, Inc. | 1987-03-13 | Traditional | PDF ↗ |
| K863223 | DIMENSION-WBG | Dimension Diagnostics | 1987-03-10 | Traditional | PDF ↗ |
| K870616 | GLUCOSE OXIDASE REAGENT | Intersect Systems, Inc. | 1987-03-06 | Traditional | PDF ↗ |
| K864322 | MPX SYSTEM, GLUCOSE TEST SYSTEM | Lifescan, Inc. | 1987-02-25 | Traditional | PDF ↗ |
| K864530 | SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. | Miles Laboratories, Inc. | 1987-02-18 | Traditional | PDF ↗ |
| K864224 | ABBOTT SPECTRUM GLUCOSE REAGENT | Abbott Laboratories | 1987-01-05 | Traditional | PDF ↗ |
| K863468 | EXACTECH(TM) | Travenol Laboratories, S.A. | 1986-12-08 | Traditional | PDF ↗ |
| K860948 | TRACKER SYSTEM | Boehringer Mannheim Corp. | 1986-12-08 | Traditional | PDF ↗ |
| K853733 | MED-PEN/MED-POINT | Garid, Inc. | 1986-12-04 | Traditional | PDF ↗ |
| K863102 | GLUCOMETER-E | J. D. Assoc. | 1986-11-24 | Traditional | PDF ↗ |
| K863948 | A-GENT(TM) LIQUID GLUCOSE TRINDER | Abbott Laboratories | 1986-11-13 | Traditional | PDF ↗ |
| K863926 | GLUCOSE OXIDASE | Tech-Co, Inc. | 1986-11-13 | Traditional | PDF ↗ |
| K862984 | UNIDEX GLUCOSE TEST STRIP | Unidex, Inc. | 1986-11-05 | Traditional | PDF ↗ |
| K862721 | ENZYMATIC BLOOD GLUCOSE | U. S. Diagnostics, Inc. | 1986-09-03 | Traditional | PDF ↗ |
| K860682 | GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET | Gambro, Inc. | 1986-08-29 | Traditional | PDF ↗ |
| K854329 | DIAGEM 300 BG REAGENT STRIPS | Seton Products, Inc. | 1986-08-04 | Traditional | PDF ↗ |
| K855178 | DIATRON BLOOD GLUCOSE METER | Dextron, Inc. | 1986-08-04 | Traditional | PDF ↗ |
| K861303 | GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER | Miles Laboratories, Inc. | 1986-07-02 | Traditional | PDF ↗ |
| K855202 | GLUCOMETER M BLOOD GULCOSE METER | Miles Laboratories, Inc. | 1986-07-02 | Traditional | PDF ↗ |
| K852960 | DIRECT | University of Wisconsin | 1986-06-16 | Traditional | PDF ↗ |
Product code CGA · Class II · Clinical Chemistry. Data: openFDA.