FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QMS VANCOMYCIN
K Number: K050419
·
Decision Apr 1, 2005
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
30
Applicant Total
28
Review Days
42
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Basic Information
- Device Name
- QMS VANCOMYCIN
- K Number
- K050419
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3950
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Seradyn, Inc.
- Date Received
- February 18, 2005
- Decision Date
- April 1, 2005
- Product Code
- LEH
- 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 |
|---|---|---|---|
| LEH | Radioimmunoassay, Vancomycin | FDA class 2 | Clinical Toxicology |
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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 |
| K060709 | MULTIGENT GENTAMICIN | Jun 15, 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 |
| 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 |