DIE — Heavy Metals Control Materials Class I
FDA Device Classification
Classification Details
- Product Code
- DIE
- Device Class
- Class I
- Regulation Number
- 862.3280
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K020610 | bio-rad | LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 | April 22, 2002 |
| K990928 | bio-rad | LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 | April 16, 1999 |
| K891691 | bio-rad | LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II | December 19, 1989 |
| K890721 | actio | SHAPE-ACTIO METAL TOXICOLOGY CONTROL | April 10, 1989 |
| K863915 | shape products | SHAPE-ACTIO METAL TOXICOLOGY CONTROL | November 24, 1986 |