FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXSYM PHENYTOIN ASSAY
K Number: K935375
·
Decision Jun 21, 1994
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
14
Applicant Total
883
Review Days
225
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Basic Information
- Device Name
- AXSYM PHENYTOIN ASSAY
- K Number
- K935375
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3350
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- November 8, 1993
- Decision Date
- June 21, 1994
- Product Code
- LGR
- 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 |
|---|---|---|---|
| LGR | Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGR), ordered by most recent decision date.
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COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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