Calcium Test Item Number 65409
by Em Diagnostic Systems, Inc. 510(k)
Active
510(k) K932158
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK932158 | Date27 Sep 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CIC
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1145
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
CALCIUM TEST ITEM NUMBER 65409 is a clinical chemistry in vitro diagnostic device used for the quantitative determination of calcium in biological samples. It operates on the principle of colorimetric analysis using a Cresolphthalein Complexone reagent, which produces a measurable color change proportional to the calcium concentration in the specimen.
The device is intended for use in clinical laboratory settings under the supervision of qualified personnel. It is supplied as a single-use test item and is designed for in vitro diagnostic use only. Storage conditions and handling instructions are specified by the manufacturer to maintain reagent integrity. The device is regulated under FDA 510(k) clearance K932158 and classified under product code CIC with regulation number 862.1145.
Other devices from Em Diagnostic Systems, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is CALCIUM TEST ITEM NUMBER 65409 used for?
This device is used for the quantitative determination of calcium levels in biological samples. It is intended for in vitro diagnostic use only in clinical laboratory settings under the supervision of qualified personnel.
How does the CALCIUM TEST 65409 measure calcium?
It operates on the principle of colorimetric analysis using a Cresolphthalein Complexone reagent. This reagent produces a measurable color change that is directly proportional to the calcium concentration in the specimen.
Is the CALCIUM TEST 65409 a single-use device?
Yes, the device is supplied as a single-use test item. It is designed for one-time use per test to ensure accuracy and prevent cross-contamination between samples.
What are the storage requirements for this calcium test?
Storage conditions and handling instructions are specified by the manufacturer to maintain reagent integrity. Users must follow these guidelines to ensure the device functions correctly and delivers reliable results.