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Panels › Clinical Chemistry › Product code LFR · Class 2

Glucose Dehydrogenase, Glucose

Regulation 862.1345

0510(k)s in 12 months (73 all time)
0recalls in 12 months (51 all time)
43recalls that name a 510(k)
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Top companies in LFR

Decided510(k)Device and applicantCode
Aug 28, 1998K982079ACCU-CHECK VOICEMATE
Boehringer Mannheim Corp.
LFR
May 22, 1998K980731ACCU-CHEK COMFORT CURVE TEST STRIPS
Boehringer Mannheim Corp.
LFR
Dec 15, 1997K973662ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS
Boehringer Mannheim Corp.
LFR
Oct 9, 1997K972876GLUCOTREND BASIC SYSTEM
Boehringer Mannheim Corp.
LFR
Oct 15, 1996K962415HEMOCUE B-GLCOSE SYSTEM
Hemocue, Inc.
LFR
Aug 23, 1996K961311HEMOCUE B-GLUCOSE SYSTEM
Hemocue, Inc.
LFR
Feb 15, 1996K954833ACCU-CHEK ADVANTAGE TEST STRIPS
Boehringer Mannheim Corp.
LFR
Sep 6, 1995K951750GLUCOSE TEST ITEM NUMBER 97375/94
Emd Chemicals, Inc.
LFR
Aug 24, 1995K951887ADVANTAGE TEST STRIPS
Boehringer Mannheim Corp.
LFR
Feb 2, 1988K870708GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM
Kyoto Daiichi Kagaku Co., Ltd., JP
LFR
Dec 18, 1987K874708EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008
Em Diagnostic Systems, Inc.
LFR
Apr 21, 1986K860726ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID
Trace Scientific , Ltd., AU
LFR
Feb 11, 1986K855080EMDS GLUCOSE TEST PACK ITEM 67656/95
Em Diagnostic Systems, Inc.
LFR
Jul 6, 1982K821867ULTRACHEM GLUC-DH
Harleco Diagnostics
LFR
Jun 2, 1982K821469ULTRACHEM GLUC-DH, #65048
Emd Chemicals, Inc.
LFR
Jun 2, 1982K821463ULTRACHEM GLUC-DH, #65048
Emd Chemicals, Inc.
LFR
Dec 31, 1981K813427ULTRACHEM GLUC-DH
Harleco
LFR
Nov 10, 1981K813042ULTRACHEM GLUC-DH SET, ITEM #65048
Harleco
LFR
May 27, 1981K811202ULTRACHEM GLUC-DH, ITEM NO. 65048
Harleco
LFR
Aug 10, 1979K791213GLUCOSE (GDH) REAGENT
Gilford Diagnostics
LFR
Aug 3, 1979K791110KINETIC DETERMINATION OF UV GLUCOSE
The Dow Chemical Co.
LFR
Dec 4, 1978K781783BLOOD SUGAR
Gilford Diagnostics
LFR
Nov 22, 1977K771102UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS
The Dow Chemical Co.
LFR

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