FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR
K Number: K083487
·
Decision Mar 30, 2009
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
4
Applicant Total
92
Review Days
125
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Basic Information
- Device Name
- EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR
- K Number
- K083487
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3840
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics
- Date Received
- November 25, 2008
- Decision Date
- March 30, 2009
- Product Code
- NRP
- 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 |
|---|---|---|---|
| NRP | Sirolimus Test System | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NRP), ordered by most recent decision date.
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