Medical Device Manufacturer · US , Walker , MI

King Diagnostics, Inc.

41 submissions · 41 cleared · Since 1981
41
Total
41
Cleared
0
Denied

King Diagnostics, Inc. — FDA 510(k) Submissions

King Diagnostics, Inc. has submitted 41 FDA 510(k) premarket notifications since 1981, of which 41 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Multipurpose For In Vitro Coagulation Studies, Acid, Uric, Uricase (colorimetric), Hexokinase, Glucose, Glucose Oxidase, Glucose, Enzymatic Esterase--oxidase, Cholesterol . Use the specialty filter in the sidebar to narrow results.

41 devices
1–25 of 41
KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT
K933329 · JMO Ferrozine (colorimetric)... · Chemistry
Oct 1993 106d
KING SODIUM/POTASSIUM STANDARD MODIFIED
K931834 · JIS Calibrator, Primary · Chemistry
Aug 1993 152d
HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)
K931773 · LBR Ldl & Vldl Precipitation,... · Chemistry
Aug 1993 129d
KING DIAGNOSTICS CK REAGENT
K931326 · CGS Nad Reduction/nadh... · Chemistry
Jun 1993 91d
KING DIAGNOSTICS GLUCOSE (HK) REAGENT
K923129 · CFR Hexokinase, Glucose · Chemistry
Nov 1992 129d
KING DIAGNOSTICS UREA NITROGEN REAGENT
K922969 · CDN Urease, Photometric, Urea... · Chemistry
Oct 1992 116d
KING DIAGNOSTICS CHLORIDE REAGENT
K922921 · CHJ Mercuric Thiocyanate,... · Chemistry
Oct 1992 110d
KING DIAGNOSTICS MAGNESIUM REAGENT
K923927 · JGJ Photometric Method,... · Chemistry
Sep 1992 56d
KING DIAGNOSTICS GAMMA GT REAGENT
K923091 · JPZ Colorimetric Method,... · Chemistry
Sep 1992 76d
KING DIAGNOSTICS CHOLESTEROL REAGENT
K923128 · CHH Enzymatic... · Chemistry
Sep 1992 75d
KING DIAGNOSTIC TRIGLYCERIDES REAGENT
K922964 · CDT Lipase... · Chemistry
Aug 1992 60d
CALCIUM (AZ III) REAGENT
K922835 · CJY Azo Dye, Calcium · Chemistry
Aug 1992 53d
KING DIAGNOSTICS AST (GOT) REAGENT
K922108 · CIT Nadh Oxidation/nad... · Chemistry
Jul 1992 71d
KING DIAGNOSTICS ALT (GPT) REAGENT
K922109 · CKA Nadh Oxidation/nad... · Chemistry
Jun 1992 30d
KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD
K920809 · JIS Calibrator, Primary · Chemistry
Apr 1992 56d
KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST
K912499 · CHH Enzymatic... · Chemistry
Sep 1991 114d
KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST
K912251 · CFR Hexokinase, Glucose · Chemistry
Jul 1991 58d
KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
K884485 · GFO Activated Partial... · Hematology
Dec 1988 64d
KD 0.1 M SODIUM CITRATE SOLUTION
K883635 · JPA System, Multipurpose For... · Hematology
Oct 1988 67d
KD 0.02 M CALCIUM CHLORIDE SOLUTION
K883637 · JPA System, Multipurpose For... · Hematology
Oct 1988 67d
KD ONE-STAGE PROTHROMBIN TIME TEST
K883640 · JPA System, Multipurpose For... · Hematology
Oct 1988 67d
CALIBRATION KIT
K882220 · JIW Calibrator, Surrogate · Chemistry
Aug 1988 68d
ACID PHOSPHATASE TEST
K873726 · CKE Acid Phosphatase,... · Chemistry
Jan 1988 134d
ALKALINE PHOSPHATASE TEST
K862498 · CJE Nitrophenylphosphate,... · Chemistry
Sep 1986 87d
KING DIAGNOSTICS LDH TEST
K862306 · CFJ Nad Reduction/nadh... · Chemistry
Aug 1986 63d
Filters