FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BILIRUBIN ASSAY ON THE OMNI S ANALYZER
K Number: K040174
·
Decision May 14, 2004
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
16
Applicant Total
264
Review Days
109
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Basic Information
- Device Name
- BILIRUBIN ASSAY ON THE OMNI S ANALYZER
- K Number
- K040174
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1113
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- January 26, 2004
- Decision Date
- May 14, 2004
- 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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