Lyphochek Whole Blood Metals Control Model # 527, 528, 529
FDA 510(k) K020610 · Bio-Rad
510(k) numberK020610
Submission
- Device name
- Lyphochek Whole Blood Metals Control Model # 527, 528, 529
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- February 25, 2002
- Decision date
- April 22, 2002
- 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 |
|---|---|---|---|
| K990928 | Lyphocheck Urine Metals Control, Item NO.400, 405DIE · Traditional | Bio-Rad | 04/16/1999SE |
| 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 |
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Questions and answers
When was Lyphochek Whole Blood Metals Control Model # 527, 528, 529 cleared by the FDA?
Lyphochek Whole Blood Metals Control Model # 527, 528, 529 (K020610) received a 510(k) decision of Substantially Equivalent on April 22, 2002, 56 days after the submission was received.
What is the product code of K020610?
The FDA product code is DIE – Heavy Metals Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.