King Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “King Diagnostics, Inc.” (first 1981, latest 1993), across 34 product codes in 2 review panels. Median 510(k) review time under this name: 60 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 3 | 3 |
| CFR | Hexokinase, Glucose | 2 | 2 |
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 2 |
| JIS | Calibrator, Primary | 2 | 2 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 2 | 2 |
| CDN | Urease, Photometric, Urea Nitrogen | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
Plus 24 more product codes.
Review panels
- Clinical Chemistry (36)
- Hematology (5)
Most recent King Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933329 | KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT | JMO | 1993-10-22 | 106 |
| K931834 | KING SODIUM/POTASSIUM STANDARD MODIFIED | JIS | 1993-08-25 | 152 |
| K931773 | HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) | LBR | 1993-08-16 | 129 |
| K931326 | KING DIAGNOSTICS CK REAGENT | CGS | 1993-06-15 | 91 |
| K923129 | KING DIAGNOSTICS GLUCOSE (HK) REAGENT | CFR | 1992-11-02 | 129 |
| K922969 | KING DIAGNOSTICS UREA NITROGEN REAGENT | CDN | 1992-10-13 | 116 |
| K922921 | KING DIAGNOSTICS CHLORIDE REAGENT | CHJ | 1992-10-05 | 110 |
| K923927 | KING DIAGNOSTICS MAGNESIUM REAGENT | JGJ | 1992-09-30 | 56 |
| K923128 | KING DIAGNOSTICS CHOLESTEROL REAGENT | CHH | 1992-09-09 | 75 |
| K923091 | KING DIAGNOSTICS GAMMA GT REAGENT | JPZ | 1992-09-09 | 76 |
31 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named King Diagnostics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- King Systems Corp. (18 510(k)s)
- King & Spalding (7 510(k)s)
- King Dental Corp. (2 510(k)s)
- King Handy Five Corp. (2 510(k)s)
- King'S Sunglass Corp. (2 510(k)s)
- King-Devick Technologies, Inc. (1 510(k)s)
- King I Tech Corporation (1 510(k)s)
- King Kondom Products, Inc. (1 510(k)s)
- King Mfg. Co. (1 510(k)s)
- King'S Bay Intl., Inc. (1 510(k)s)
- King Tool, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under King Diagnostics, Inc.?
FDA lists 41 510(k) clearances under the applicant name “King Diagnostics, Inc.” (first 1981, latest 1993), across 34 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by King Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name King Diagnostics, Inc. is 60 days.
Which FDA product codes appear under King Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JPA (System, Multipurpose For In Vitro Coagulation Studies, 3); CFR (Hexokinase, Glucose, 2); CGA (Glucose Oxidase, Glucose, 2).
Next steps
- See all 41 King Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JPA, King Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.