Heavy Metals Control Materials
The Heavy Metals Control Materials are reference standards used in clinical toxicology laboratories to calibrate and validate analytical methods for the detection and quantification of heavy metals such as lead, mercury, and arsenic in biological specimens. This device is classified as FDA Class 1, indicating low risk, and is subject only to general controls without premarket notification requirements. It is regulated under 21 CFR 862.3280 within the Clinical Toxicology specialty.
Research product code DIE in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- DIE
- Device Class
- FDA class 1
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K020610 | LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 | Apr 22, 2002 | Substantially Equivalent | Bio-Rad |
| K990928 | LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 | Apr 16, 1999 | Substantially Equivalent | Bio-Rad |
| K891691 | LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II | Dec 19, 1989 | Substantially Equivalent | Bio-Rad |
| K890721 | SHAPE-ACTIO METAL TOXICOLOGY CONTROL | Apr 10, 1989 | Substantially Equivalent | Actio, Inc. |
| K863915 | SHAPE-ACTIO METAL TOXICOLOGY CONTROL | Nov 24, 1986 | Substantially Equivalent | Shape Products Co. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.