FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXSYM GENTAMICIN
K Number: K935376
·
Decision Jun 21, 1994
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
36
Applicant Total
14
Review Days
225
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Basic Information
- Device Name
- AXSYM GENTAMICIN
- K Number
- K935376
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3450
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Mfg., Inc.
- Date Received
- November 8, 1993
- Decision Date
- June 21, 1994
- Product Code
- LCD
- 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 |
|---|---|---|---|
| LCD | Enzyme Immunoassay, Gentamicin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
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Other Clearances by Abbott Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981457 | ALBP | May 27, 1998 | Substantially Equivalent |
| K981232 | CA | May 18, 1998 | Substantially Equivalent |
| K981231 | CO2 | May 12, 1998 | Substantially Equivalent |
| K965230 | ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP | Jul 3, 1997 | Substantially Equivalent |
| K971293 | LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE | Jun 27, 1997 | Substantially Equivalent |
| K953656 | ABBOTT IMX PROLACTIN(MODIFICATION) | Oct 3, 1995 | Substantially Equivalent |
| K953657 | ABBOTT AXSYM PROLACTIN(MODIFICATION) | Sep 25, 1995 | Substantially Equivalent |
| K944669 | FLEXIFLO QUANTUM ENTERAL PUMP | Jul 24, 1995 | Substantially Equivalent |
| K943691 | IMX FOLATE | Mar 23, 1995 | Substantially Equivalent |
| K943733 | FLEXIFLO SIX ENTERAL NUTRITION PUMP | Dec 12, 1994 | Substantially Equivalent - Subject to Tracking Reg. |