Panels › Clinical Chemistry › Product code CFR · Class 2
Hexokinase, Glucose
Regulation 862.1345
1510(k)s in 12 months (145 all time)
0recalls in 12 months (22 all time)
21recalls that name a 510(k)
Top companies in CFR
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 1997 | K970664 | GLUCOSE REAGENT Derma Media Lab., Inc. | CFR |
| Jul 22, 1997 | K971754 | LIQUID GLUCOSE (HEXOKINASE) REAGENT SET Pointe Scientific, Inc., | CFR |
| Jun 16, 1997 | K971467 | SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) Carolina Liquid Chemistries Corp. | CFR |
| Jun 16, 1997 | K971276 | GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER Bayer Corp. | CFR |
| Feb 10, 1997 | K964004 | GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS Bayer Corp. | CFR |
| Dec 26, 1996 | K962435 | STC AUTO-LYTE URINARY GLUCOSE ASSAY OraSure Technologies, Inc. | CFR |
| Oct 25, 1996 | K953210 | GLUCOSE (HEXOKINASE) KIT Randox Laboratories, Ltd., IE | CFR |
| Jun 21, 1996 | K961282 | GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60 Diagnostic Chemicals , Ltd., CA | CFR |
| Apr 4, 1996 | K960084 | HICHEM GLUCOSE/HK REAGENT KIT Hi Chem, Inc. | CFR |
| Feb 13, 1996 | K953847 | ROCHE REAGENT FOR GLUCOSE Roche Diagnostic Systems, Inc. | CFR |
| Oct 3, 1995 | K952437 | DMA GLUCOSE HEXOKINASE U.V. PROCEDURE Data Medical Associates, Inc. | CFR |
| Jun 1, 1995 | K951058 | GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION Heraeus Kulzer, Inc. | CFR |
| May 8, 1995 | K945908 | GLUCOSE (HK) REAGENT (PROCEDURE NO.16) Sigma Diagnostics, Inc. | CFR |
| Mar 15, 1995 | K944406 | OLYMPUS GLUCOSE REAGENT Olympus America, Inc. | CFR |
| Dec 29, 1994 | K942963 | GLUCOSE QVET Prisma Systems | CFR |
| Dec 7, 1993 | K934900 | GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION Heraeus Kulzer, Inc. | CFR |
| Oct 12, 1993 | K931402 | IL TEST GLUCOSE Instrumentation Laboratory CO | CFR |
| Jul 22, 1993 | K931890 | GLUCOSE-HK TEST Em Diagnostic Systems, Inc. | CFR |
| Jun 24, 1993 | K926361 | GLUCOMETER ENCORE QA BLOOD GLUCOSE METER Heraeus Kulzer, Inc. | CFR |
| Jan 27, 1993 | K922811 | ROCHE COBAS FUTURA GLUCOSE Roche Diagnostic Systems, Inc. | CFR |
| Dec 3, 1992 | K924601 | OLYMPUS GLUCOSE REAGENT Olympus Corp. | CFR |
| Nov 25, 1992 | K924572 | EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 Em Diagnostic Systems, Inc. | CFR |
| Nov 2, 1992 | K923129 | KING DIAGNOSTICS GLUCOSE (HK) REAGENT King Diagnostics, Inc. | CFR |
| Sep 23, 1992 | K923018 | ENCORE TEST STRIPS Heraeus Kulzer, Inc. | CFR |
| Sep 15, 1992 | K923040 | MILES URINE GLUCOSE METHOD Heraeus Kulzer, Inc. | CFR |
| Jul 16, 1992 | K922232 | OLYMPUS GLUCOSE REAGENT Olympus Corp. | CFR |
| Dec 18, 1991 | K914794 | TECHNICON CHEM 1 PLASMA GLUCOSE Heraeus Kulzer, Inc. | CFR |
| Jul 30, 1991 | K912808 | ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15 Em Diagnostic Systems, Inc. | CFR |
| Jul 18, 1991 | K912251 | KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST King Diagnostics, Inc. | CFR |
| Mar 11, 1991 | K905227 | GLUCOSE (HK) REAGENT, UNIVERSAL Enzyme Technology, Inc. | CFR |
| Jan 4, 1991 | K905144 | ECLIPSE ICA GLUCOSE Biotope, Inc. | CFR |
| Mar 29, 1990 | K901122 | TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE Technicon Instruments Corp. | CFR |
| Mar 9, 1990 | K897160 | COULTER GLUCOSE REAGENT Coulter Electronics, Inc. | CFR |
| Nov 14, 1989 | K896028 | GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600 American Research Products Co. | CFR |
| Oct 3, 1989 | K894394 | ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT Abbott Laboratories | CFR |
| Sep 7, 1989 | K894483 | GLUCOSE-HK TEST (GLU-HK) ITEM #65415 Em Diagnostic Systems, Inc. | CFR |
| Jun 20, 1989 | K891923 | AMRESCO PRODUCT NUMBER 7426 American Research Products Co. | CFR |
| Jan 3, 1989 | K884736 | GLUCOSE-HK TEST (GLUC-HK) ITEM #65665 Em Diagnostic Systems, Inc. | CFR |
| Nov 10, 1988 | K884021 | EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95 Em Diagnostic Systems, Inc. | CFR |
| Aug 9, 1988 | K882334 | ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT Abbott Laboratories | CFR |
| Mar 15, 1988 | K880236 | GLUCOSE HEXOKINASE Tech-Neal Scientific, Inc. | CFR |
| Mar 3, 1988 | K874846 | GLUCOSE (HEXOKINASE) Tech-Co, Inc. | CFR |
| Nov 24, 1987 | K873835 | GLUCOSE-HK REAGENT Intersect Systems, Inc. | CFR |
| Nov 23, 1987 | K873936 | MODIFIED PARAMAX GLUCOSE REAGENT Baxter Healthcare Corp | CFR |
| Jun 5, 1987 | K871976 | MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919 Simmler, Inc. | CFR |
| Apr 29, 1987 | K871456 | ULTRA-VIOLET GLUCOSE REAGENT KIT Biochemical Trade, Inc. | CFR |
| Sep 26, 1986 | K863259 | GLUCOSE HK PROCEDURE Data Medical Associates, Inc. | CFR |
| Apr 24, 1986 | K861311 | GLUCOSE (HEXOKINASE) REAGENT SET Sterling Diagnostics, Inc. | CFR |
| Apr 7, 1986 | K860724 | ENZYMATIC GLUCOSE REAGENT (HEXOKINASE) Trace Scientific , Ltd., AU | CFR |
| Mar 17, 1986 | K860625 | GLUCOSE HK-60 ASSAY KIT CAT. #201-39 Diagnostic Chemicals, Ltd. (Usa) | CFR |
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