Lyphocheck Urine Metals Control, Item NO.400, 405
FDA 510(k) K990928 · Bio-Rad
510(k) numberK990928
Submission
- Device name
- Lyphocheck Urine Metals Control, Item NO.400, 405
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- March 19, 1999
- Decision date
- April 16, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DIE – Heavy Metals Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020610 | Lyphochek Whole Blood Metals Control Model # 527, 528, 529DIE · Traditional | Bio-Rad | 04/22/2002SE |
| K891691 | Lyphochek Urine Metals Control, Levels I and IIDIE · Traditional | Bio-Rad | 12/19/1989SE |
| K890721 | Shape-Actio Metal Toxicology ControlDIE · Traditional | Actio, Inc. | 04/10/1989SE |
| K863915 | Shape-Actio Metal Toxicology ControlDIE · Traditional | Shape Products Co. | 11/24/1986SE |
More from Shape Products Co.
| 510(k) | Device | Decision |
|---|---|---|
| K171061 | MRSASelect IIJSO · Traditional | 12/28/2017SE |
| K122187 | Vreselect Culture MediumJSO · Traditional | 11/06/2012SE |
| K103684 | Vreselect Culture MediumJSO · Traditional | 10/21/2011SE |
| K093678 | Platelia Aspergillus Eia Model 62793NOM · Traditional | 01/13/2011SE |
| K100589 | Mrsa Select - Skin and Soft Tissue Wound SpecimensJSO · Traditional | 10/29/2010SE |
| K081362 | Platelia Lyme IgmLSR · Traditional | 06/26/2008SE |
| K081212 | Mrsaselect - Extended IncubationJSO · Traditional | 06/13/2008SE |
| K080012 | Platelia Lyme Igg AssayLSR · Traditional | 05/08/2008SE |
| K070361 | MrsaselectJSO · Traditional | 09/13/2007SE |
| K060641 | Platelia Aspergillus Eia, Model 62793NOM · Traditional | 06/02/2006SE |
Questions and answers
When was Lyphocheck Urine Metals Control, Item NO.400, 405 cleared by the FDA?
Lyphocheck Urine Metals Control, Item NO.400, 405 (K990928) received a 510(k) decision of Substantially Equivalent on April 16, 1999, 28 days after the submission was received.
What is the product code of K990928?
The FDA product code is DIE – Heavy Metals Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.