Km - Kal 1
510(k) K823024
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823024 | Date16 Nov 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JIT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1150
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The Km - Kal 1 is a Calibrator, Secondary, classified under the medical specialty of Clinical Chemistry. It is a device used in clinical chemistry applications. The device has a product code of JIT and is regulated under the regulation number 862.1150.
The Km - Kal 1 is supplied by Kmn Products, Inc. and has been granted FDA 510(k) clearance, with a decision date of November 16, 1982. The device is associated with the k number K823024 and has a registration number. It is intended for use in clinical chemistry settings, with specific storage and handling requirements not specified in the provided data.
Other devices from Kmn Products, Inc.
Questions
AI-generated answers, 28 Sep 2026
What is the Km - Kal 1 used for?
The Km - Kal 1 is used in clinical chemistry applications as a secondary calibrator.
What type of clearance does the Km - Kal 1 have?
The Km - Kal 1 has been granted FDA 510(k) clearance, indicating it is substantially equivalent to a predicate device.
What are the storage and handling requirements for the Km - Kal 1?
The storage and handling requirements for the Km - Kal 1 are not specified in the provided data, but it is intended for use in clinical chemistry settings.