FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAPIDPOINT 405 NEONATAL BILIRUBIN
K Number: K110277
·
Decision Aug 15, 2011
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
16
Applicant Total
92
Review Days
196
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Basic Information
- Device Name
- RAPIDPOINT 405 NEONATAL BILIRUBIN
- K Number
- K110277
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1113
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics
- Date Received
- January 31, 2011
- Decision Date
- August 15, 2011
- Product Code
- MQM
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| MQM | Bilirubin (Total And Unbound) In The Neonate Test System | FDA class 1 | Clinical Chemistry |
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