Product Code: JFN
FDA class 2
21 CFR 862.1145
Atomic Absorption, Calcium
Clinical Chemistry
Atomic Absorption for Calcium is a clinical chemistry test system employing atomic absorption spectroscopy to quantitatively measure calcium levels in blood or other biological specimens, supporting diagnosis of hypercalcemia, hypocalcemia, and related metabolic conditions. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and compliance with general and special controls. The product code is JFN, regulated under 21 CFR 862.1145, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
14
Basic Information
- Product Code
- JFN
- Device Class
- FDA class 2
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K914510 | CALCIUM/LITHIUM TEST BECKMAN SYNCHRON EL-ISE ANALY | Nov 19, 1991 | Substantially Equivalent | Beckman Instruments, Inc. |
| K871903 | QUICK QUALITATIVE CALCIUM TEST (QUICK-CAL) | Sep 02, 1987 | Substantially Equivalent | Creative Scientific Technology, Inc. |
| K770570 | CALCIUM/MAGNESIUM ANALYZER | Jun 08, 1977 | Substantially Equivalent | Beckman Instruments, Inc. |