Company ยท US
King Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1993. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 3 |
| CFR | Hexokinase, Glucose | 2 |
| CGA | Glucose Oxidase, Glucose | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 |
| JIS | Calibrator, Primary | 2 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 2 |
| CDN | Urease, Photometric, Urea Nitrogen | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CGE | Orthotoluidine, Glucose | 1 |
| CGO | Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 |
| CHO | Radioimmunoassay, Cyclic Amp | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 1993 | K933329 | KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT King Diagnostics, Inc. | JMO |
| Aug 25, 1993 | K931834 | KING SODIUM/POTASSIUM STANDARD MODIFIED King Diagnostics, Inc. | JIS |
| Aug 16, 1993 | K931773 | HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) King Diagnostics, Inc. | LBR |
| Jun 15, 1993 | K931326 | KING DIAGNOSTICS CK REAGENT King Diagnostics, Inc. | CGS |
| Nov 2, 1992 | K923129 | KING DIAGNOSTICS GLUCOSE (HK) REAGENT King Diagnostics, Inc. | CFR |
| Oct 13, 1992 | K922969 | KING DIAGNOSTICS UREA NITROGEN REAGENT King Diagnostics, Inc. | CDN |
| Oct 5, 1992 | K922921 | KING DIAGNOSTICS CHLORIDE REAGENT King Diagnostics, Inc. | CHJ |
| Sep 30, 1992 | K923927 | KING DIAGNOSTICS MAGNESIUM REAGENT King Diagnostics, Inc. | JGJ |
| Sep 9, 1992 | K923128 | KING DIAGNOSTICS CHOLESTEROL REAGENT King Diagnostics, Inc. | CHH |
| Sep 9, 1992 | K923091 | KING DIAGNOSTICS GAMMA GT REAGENT King Diagnostics, Inc. | JPZ |
| Aug 18, 1992 | K922964 | KING DIAGNOSTIC TRIGLYCERIDES REAGENT King Diagnostics, Inc. | CDT |
| Aug 4, 1992 | K922835 | CALCIUM (AZ III) REAGENT King Diagnostics, Inc. | CJY |
| Jul 15, 1992 | K922108 | KING DIAGNOSTICS AST (GOT) REAGENT King Diagnostics, Inc. | CIT |
| Jun 4, 1992 | K922109 | KING DIAGNOSTICS ALT (GPT) REAGENT King Diagnostics, Inc. | CKA |
| Apr 17, 1992 | K920809 | KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD King Diagnostics, Inc. | JIS |
| Sep 27, 1991 | K912499 | KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST King Diagnostics, Inc. | CHH |
| Jul 18, 1991 | K912251 | KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST King Diagnostics, Inc. | CFR |
| Dec 28, 1988 | K884485 | KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT King Diagnostics, Inc. | GFO |
| Oct 31, 1988 | K883640 | KD ONE-STAGE PROTHROMBIN TIME TEST King Diagnostics, Inc. | JPA |
| Oct 31, 1988 | K883637 | KD 0.02 M CALCIUM CHLORIDE SOLUTION King Diagnostics, Inc. | JPA |
| Oct 31, 1988 | K883635 | KD 0.1 M SODIUM CITRATE SOLUTION King Diagnostics, Inc. | JPA |
| Aug 2, 1988 | K882220 | CALIBRATION KIT King Diagnostics, Inc. | JIW |
| Jan 27, 1988 | K873726 | ACID PHOSPHATASE TEST King Diagnostics, Inc. | CKE |
| Sep 26, 1986 | K862498 | ALKALINE PHOSPHATASE TEST King Diagnostics, Inc. | CJE |
| Aug 19, 1986 | K862306 | KING DIAGNOSTICS LDH TEST King Diagnostics, Inc. | CFJ |
| Jul 8, 1986 | K862208 | KING DIAGNOSTICS URIC ACID TEST King Diagnostics, Inc. | KNK |
| Jul 6, 1983 | K831411 | GLUCOSE OXIDASE/PEROXIDASE TEST King Diagnostics, Inc. | CGA |
| Mar 11, 1982 | K820418 | K.D. COLORIMETRIC BLOOD UREA N2 TEST King Diagnostics, Inc. | JGZ |
| Aug 25, 1981 | K812127 | KING DIAGNOSTICS HEMOGLOBIN TEST King Diagnostics, Inc. | GKR |
| Jul 23, 1981 | K811883 | KING DIAGNOSTICS GLUCOSE-O TEST King Diagnostics, Inc. | CGE |
| Jul 23, 1981 | K811882 | KING DIAGNOSTICS GLUCOSE TEST King Diagnostics, Inc. | CGA |
| Jul 23, 1981 | K811881 | KING DIAGNOSTICS TOTAL BILIRUBIN TEST King Diagnostics, Inc. | CIG |
| Jul 10, 1981 | K811749 | KING DIAGNOSTICS PHOSPHORUS TEST King Diagnostics, Inc. | CEO |
| Jul 10, 1981 | K811748 | KING DIAGNOSTICS CALCIUM TEST King Diagnostics, Inc. | CIC |
| Jul 10, 1981 | K811747 | KING DIAGNOSTICS CHOLESTEROL TEST King Diagnostics, Inc. | CGO |
| Jul 10, 1981 | K811746 | KING DIAGNOSTICS CHOLESTEROL-FE TEST King Diagnostics, Inc. | CHO |
| Jul 1, 1981 | K811687 | URIC ACID TEST King Diagnostics, Inc. | KNK |
| Jun 25, 1981 | K811673 | TOTAL PROTEIN TEST King Diagnostics, Inc. | CEK |
| Jun 25, 1981 | K811664 | CREATININE TEST King Diagnostics, Inc. | CGX |
| Jun 25, 1981 | K811662 | ALBUMIN TEST King Diagnostics, Inc. | CIX |
| Jun 25, 1981 | K811661 | POTASSIUM TEST King Diagnostics, Inc. | CEJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||