FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TOBRAMYCIN LIQUID CONTROL SERUM
K Number: K792264
·
Decision Dec 18, 1979
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
82
Applicant Total
7
Review Days
39
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Basic Information
- Device Name
- TOBRAMYCIN LIQUID CONTROL SERUM
- K Number
- K792264
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Hemometrix
- Date Received
- November 9, 1979
- Decision Date
- December 18, 1979
- Product Code
- LAS
- 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 |
|---|---|---|---|
| LAS | Drug Specific Control Materials | FDA class 1 | Clinical Toxicology |
Similar 510(k) Clearances
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Other Clearances by Hemometrix
| K Number | Device Name | ||
|---|---|---|---|
| K800037 | PLATELET RETENTION (ADHESION) COLUMNS | Feb 5, 1980 | Substantially Equivalent |
| K792262 | GENTAMICIN LIQUID CONTROL SERUM | Dec 18, 1979 | Substantially Equivalent |
| K792260 | AMIKACIN LIQUID CONTROL SERUM | Dec 18, 1979 | Substantially Equivalent |
| K792263 | TOBRAMYCIN CONTROL SERUM | Dec 18, 1979 | Substantially Equivalent |
| K792261 | GENTAMICIN CONTROL SERUM | Dec 18, 1979 | Substantially Equivalent |
| K792259 | AMIKACIN CONTROL SERUM | Dec 18, 1979 | Substantially Equivalent |