510(k) K891691
- Device
- Lyphochek Urine Metals Control, Levels I And Ii
- Applicant
- BIO-RAD
- 510(k) number
- K891691
- Product code
- DIE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-12-19
- Date received
- 1989-03-22
- Regulation
- 862.3280
- Classification name
- Heavy Metals Control Materials
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNN C SHANTA
- Address
- 4000 Alfred Nobel Dr. Hercules CA US 94547 94547
FDA Registration Numbers#
- 2016706
- 3010127294
- 3001431095
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DIE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K020610 | LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 | Bio-Rad | 2002-04-22 |
| K990928 | LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 | Bio-Rad | 1999-04-16 |
| K890721 | SHAPE-ACTIO METAL TOXICOLOGY CONTROL | Actio, Inc. | 1989-04-10 |
| K863915 | SHAPE-ACTIO METAL TOXICOLOGY CONTROL | Shape Products Co. | 1986-11-24 |