FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS
K Number: K952555
·
Decision Jul 31, 1995
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
2
Applicant Total
296
Review Days
59
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Basic Information
- Device Name
- COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS
- K Number
- K952555
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3350
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Roche Diagnostic Systems, Inc.
- Date Received
- June 2, 1995
- Decision Date
- July 31, 1995
- Product Code
- MOJ
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| MOJ | Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free) | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOJ), ordered by most recent decision date.
ONLINE TDM Phenytoin - Free Phenytoin application
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TDX(R)/TDXFLX(R) FREE PHENYTOIN II
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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| K983555 | ABUSCREEN ONLINE BENZ 200 CALIBRATORS | Dec 15, 1998 | Substantially Equivalent |
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