FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTIGENT GENTAMICIN
K Number: K060709
·
Decision Jun 15, 2006
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
36
Applicant Total
28
Review Days
91
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Basic Information
- Device Name
- MULTIGENT GENTAMICIN
- K Number
- K060709
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3450
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Seradyn, Inc.
- Date Received
- March 16, 2006
- Decision Date
- June 15, 2006
- 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
Other 510(k) clearances with the same product code (LCD), ordered by most recent decision date.
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VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE
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ROCHE ONLINE GENTAMICIN
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IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
FDA 510(k)
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Other Clearances by Seradyn, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K070645 | SERADYN QMS TOPIRAMATE | May 17, 2007 | Substantially Equivalent |
| K062966 | QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS | Jan 12, 2007 | Substantially Equivalent |
| K062204 | ARCHITECT CORTISOL ASSAY | Sep 22, 2006 | Substantially Equivalent |
| K060998 | QMS TOBRAMYCIN | Jul 21, 2006 | Substantially Equivalent |
| K052826 | QMS QUINIDINE. QMS QUINIDINE CALIBRATORS | Dec 23, 2005 | Substantially Equivalent |
| K051211 | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS | Nov 18, 2005 | Substantially Equivalent |
| K052815 | QMS AMIKACIN REAGENTS | Nov 1, 2005 | Substantially Equivalent |
| K050419 | QMS VANCOMYCIN | Apr 1, 2005 | Substantially Equivalent |
| K042307 | ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) | Nov 3, 2004 | Substantially Equivalent |
| K033674 | MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS | Feb 9, 2004 | Substantially Equivalent |