FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INNOFLOUR TOBRAMYCIN
K Number: K841866
·
Decision May 31, 1984
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
9
Applicant Total
6
Review Days
27
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Basic Information
- Device Name
- INNOFLOUR TOBRAMYCIN
- K Number
- K841866
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3900
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Innotron Diagnostics
- Date Received
- May 4, 1984
- Decision Date
- May 31, 1984
- Product Code
- LFW
- 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 |
|---|---|---|---|
| LFW | Fluorescence Polarization Immunoassay, Tobramycin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
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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 |
| K841707 | INNOFLUOR PHENOBARBITAL | May 23, 1984 | Substantially Equivalent |
| K841706 | INNOFLUOR PHENYTOIN | May 22, 1984 | Substantially Equivalent |