FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INNOFLUOR PHENYTOIN
K Number: K841706
·
Decision May 22, 1984
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
14
Applicant Total
6
Review Days
29
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Basic Information
- Device Name
- INNOFLUOR PHENYTOIN
- K Number
- K841706
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3350
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Innotron Diagnostics
- Date Received
- April 23, 1984
- Decision Date
- May 22, 1984
- Product Code
- LGR
- 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 |
|---|---|---|---|
| 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.
ACS PHENYTOIN ASSAY
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INNOFLUOR PHENYTOIN ASSAY SYSTEM
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AXSYM PHENYTOIN II
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TDX(R)/TDXFLX(R) PHENYTOIN II
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PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
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FDA Class 2
·Clinical Toxicology
AXSYM PHENYTOIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Innotron Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K850629 | INNOFLUOR THEOPHYLLINE | Mar 12, 1985 | Substantially Equivalent |
| K844721 | INNOFLUOR PRIMIDONE | Jan 8, 1985 | Substantially Equivalent |
| K841865 | INNOFLOUR GENTAMICIN | May 31, 1984 | Substantially Equivalent |
| K841866 | INNOFLOUR TOBRAMYCIN | May 31, 1984 | Substantially Equivalent |
| K841707 | INNOFLUOR PHENOBARBITAL | May 23, 1984 | Substantially Equivalent |