KM-KAL 4
510(k) K823020
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823020 | 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- Withdrawn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, 22 Sep 2026
The KM-KAL 4 is a secondary calibrator used in clinical chemistry. It is a device class 2 product with product code JIT and regulation number 862.1150.
It received FDA 510(k) clearance (K823020) on November 16, 1982, as substantially equivalent. The device is manufactured by Kmn Products, Inc. and is intended for use in clinical chemistry settings.
Other devices from Kmn Products, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the KM-KAL 4 used for?
The KM-KAL 4 is a secondary calibrator intended for use in clinical chemistry settings to ensure the accuracy and consistency of test results by providing a known reference standard for instrument calibration.
How is the KM-KAL 4 supplied and is it sterile or single-use?
The device data does not specify supply format, sterility, or single-use/reuse status; therefore, no information about its physical presentation, packaging, or reuse limitations can be derived from the provided details.
What regulatory pathway was used for the KM-KAL 4 and when was it cleared?
The KM-KAL 4 received FDA 510(k) clearance via the traditional pathway on November 16, 1982, under submission number K823020, based on a determination of substantial equivalence to a legally marketed predicate device.