FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II
K Number: K891691
·
Decision Dec 19, 1989
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
4
Applicant Total
319
Review Days
272
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Basic Information
- Device Name
- LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II
- K Number
- K891691
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Bio-Rad
- Date Received
- March 22, 1989
- Decision Date
- December 19, 1989
- Product Code
- DIE
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DIE | Heavy Metals Control Materials | FDA class 1 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DIE), ordered by most recent decision date.
LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529
FDA 510(k)
FDA Class 1
·Clinical Toxicology
LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405
FDA 510(k)
FDA Class 1
·Clinical Toxicology
SHAPE-ACTIO METAL TOXICOLOGY CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
SHAPE-ACTIO METAL TOXICOLOGY CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
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