King Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 41
What King Diagnostics, Inc. makes
King Diagnostics, Inc. produces in vitro diagnostic reagents and test kits for clinical chemistry, including phosphorus, potassium, acid phosphatase, lactate dehydrogenase (LDH), albumin, creatine kinase (CK), alanine transaminase (ALT/GPT), glucose (hexokinase method), hemoglobin, and chloride assays. The company also offers calibration solutions, such as calcium chloride, and glucose reagent strips for point-of-care testing.
The portfolio includes devices regulated as Class I and Class II under the FDA’s 510(k) pathway. These products are listed in the FDA’s 510(k) database, reflecting their regulatory clearance for commercial distribution in the United States.
Catalogue
Search and filter all 41 devicesFrequently asked questions
How many devices does King Diagnostics, Inc. have in the registry?
The registry currently lists 41 devices for King Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list King Diagnostics, Inc.'s devices?
Among its 41 most recently registered devices, King Diagnostics, Inc. has devices listed in FDA 510(k) (41 devices).
What risk classes do King Diagnostics, Inc.'s devices fall under?
Among its 41 most recently registered devices, the classes recorded for King Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from King Diagnostics, Inc. in the registry?
The most recently registered devices listed for King Diagnostics, Inc. include KING DIAGNOSTICS PHOSPHORUS TEST, POTASSIUM TEST, ACID PHOSPHATASE TEST and CALIBRATION KIT.